Safety notice of the Class 1 recall of Jaundice Meter JM-103 and Jaundice Meter JM-105.1,3 Ensure that the labels developed to inform users how to interpret the out of range display are applied directly to JM-105 and JM-103 meters per the instructions of the manufacturer.1,3. Jun 22, 2018 The JM-105 is a modification of the JM-103 jaundice meter. The basic functionality, including the measuring probe, hardware, and software used to process the measurements, are identical to the JM-103. Drager jaundice-meter-jm-103-user-manual dr ger jaundice meter jm- 103: pin. Drager Bilimeter Manual - YouTube: pin. Used RESPIRONICS BiliChek Bilirubinometer For Sale - DOTmed RESPIRONICS BiliChek Bilirubinometer for sale: pin. Transcutaneous bilirubin measurement: Comparison of Respironics. Intended Use Indications for the Use of the Jaundice Meter (JM-103) The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. Staff responsible for using the Jaundice Meter JM-105 will receive a demonstration of the JM-105 by an experienced Jaundice Meter JM-105 operator OR will view the Jaundice Meter JM-105 training video. Learners are also responsible for reading the information provided in the Operating Instructions Manual.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
Recalled Product:
- Name: Jaundice Meter JM-103 and Jaundice Meter JM-105
- Product code: MQM
- Model numbers: JM-103: MU20606; JM-105: MU20105
- Manufacturing Dates: JM-103 June 2008 to August 2017, JM-105 September 2013 to April 2018
- Distribution Dates: JM-103 July 2008 to September 2017, JM-105 October 2013 to April 2018
- Devices Recalled in the U.S.: JM-103: 2449; JM-105: 2063
Device Use
The JM-103 and JM-105 Jaundice Meters are non-invasive transcutaneous bilirubinometers, which measure yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with blood levels of bilirubin in newborn infants. High levels of bilirubin (hyperbilirubinemia) may indicate jaundice or other conditions which require medical attention.
The device is intended for use in hospitals or doctors' offices under a physician's supervision or at their direction to assist clinicians in monitoring newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device along with other clinical assessments and laboratory measurements.
The JM-105 is a modification of the JM-103 jaundice meter. The basic functionality, including the measuring probe, hardware, and software used to process the measurements, are identical to the JM-103. The display of the JM-105 includes a larger screen and touchscreen, and data storage and transmission functionality.
Reason for Recall
Draeger Medical Systems, Inc. is recalling their Jaundice Meter JM-103 and JM-105 models which are used to measure bilirubin in newborn infants. The meters are being recalled because users have misinterpreted display messages that have resulted in serious injuries. Specifically, the JM-103 Meter displays three blinking dashes (- - -) and the JM-105 Meter displays dash-zero-dash (-0-) when the bilirubin level in the patient is higher than the maximum level of detection (>340µmol or 20mg/dl). Measurement of high bilirubin indicates a need for immediate medical evaluation. Some users have interpreted the two display messages as indicating a 'low' or 'zero' value instead of high bilirubin levels. When this happens, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some newborns/infants.
The out of range display is visible; however, the interpretation of the reading is not intuitive or clear. Uncertainty about the out of range indication on the Jaundice meter could cause a delay of treatment in a patient with hyperbilirubinemia.
The misuse of display information could increase risk for serious adverse health consequences such as acute and/or chronic brain damage or death.
Who May be Affected
Newborn infants who are being monitored by a physician for hyperbilirubinemia.
What to Do
Draeger Medical issued an Urgent Medical Device Safety Notice to customers with the following instructions:
- Ensure that all JM-105 and JM-103 devices are labeled per the instructions provided by the firm in a timely manner. Draeger provided their users with labels which should be applied directly onto the meter to remind the user of the meaning of the blinking (---) for the JM-103 model, and (-0- ) for the JM-105 model. The label has a picture of the out of range display messages as they appear on the meter with three blinking (---) for JM-103 or (-0-) for JM-105: and the interpretation of the messages stating 'Measurement out of range >340µmol/L/20mg/dL.'
- Provide training to all users in the clinical environment on how to use the equipment, and ensure that they understand that this is a screening device not to be used as a standalone diagnostic device.
- Perform a blood test if they obtain a bilirubin measurement that is above the device maximum value of 20mg/dL or 340µmol.
- Complete and return the Customer Reply card sent by the firm.
- Look for a separate communication letter from Draeger which notifies those using JM-105 about the availability of upgraded software and provides instructions for sending the device to the firm if they choose to have the upgrade implemented.
Jm 103 Manual
Contact Information
Draeger Medical Systems, Inc.
3135 Quarry Road, Telford Pennsylvania
USA 18969-1042
Full List of Affected Devices
Date Recall Initiated
May 21, 2018
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
Regulated Product(s)
Topic(s)
- News
DESCRIPTION
Take the sting out of screeningTranscutaneous bilirubin (TcB) measurement offers a gentle, pain-free alternative to traditional jaundice screening. There’s no blood draw, removing a major stress from fragile babies and their parents. Think of it – no more delays waiting for laboratory results. When used with other clinical signs, it is just reliable information for expert decision-making.
Because the Dräger Jaundice Meter JM-103 features a reusable probe tip, it requires no costly disposables. With the volume of screenings performed in the nursery, the cost of such disposable items can quickly exceed the initial cost of the device itself. What you get with the Dräger Jaundice Meter JM-103 is consistent quality, cost-effectively delivered over the lifetime of the device.
The Dräger Jaundice Meter JM-103 is a solution specifically designed to efficiently overcome the challenges faced when managing jaundice. Complete this vital task in the fewest possible steps to free up more time for infant care. Its ergonomic, compact design promotes ease of use, while long battery life enables you to get more done between charges.
FORUMSView All (10)
Ask a New Question0Replies4 years ago | 4 years agoIs this a point of care device requiring Lab oversite Is this a point of care device? Is this a waived test? Reply |
| -Biomedprn 4 years ago | 4 years agoCalibration Procedure Is there a calibration for this JM-103 if the tests are outside of the stated values with their tolerances? Reply |
1Reply4 years ago | 4 years agoOperator's Manual Need manual to learn how to test jaundice meter for accuracy, specifically the parameters as I know how to perform the test. Reply |
DOCUMENTS / MANUALSView All
VIDEOS
FEATURES
- Reusable Probe - Just wipe with alcohol and reuse as needed. There are no disposable tips to fumble with, keep track of or reorder.
- Portable Convenience - Compact device fits easily in hand or pocket and allows for quick clean-up between uses.
- Ergonomic Design - Controls assure convenient operation while helping seal out contaminants and extend device life.
- Easy-to-read Display - See results in seconds, not hours. Large numbers help ensure accurate interpretation. Results are shown in mg/dL or Μmol/L as selected by user.
SPECIFICATIONS
| Height | 15.4 cm |
| Length | 3.2 cm |
| Weight | 150 g |
| Width | 4.8 cm |
Additional Specifications
Operating temp: 10C to 40C
AC adapter output: 9V, 500 mA, 4.5W
FDA AlertsView All
Class 1 Recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103...Jm 103 Jaundice Meter Manual Diagram
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death