MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER

Model Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.
Additional Manufacturer Narrative
A complaint was received involving inconsistent readings between the jm-105 transcutaneous bilirubin (tcb) and total serum bilirubin (tsb) blood test results.No adverse patient impact was reported.It was confirmed that the device was being used correctly.Data, collected by the customer, was provided to the product manager and marketing manager/ registered respiratory therapist (rrt) for review.Based on the rrt's evaluation of the data, it was recommended that the device be returned to draeger for calibration and training be reviewed with the customer.The customer declined retraining but agreed to send the device back to draeger for recalibration.Upon return of the device, the service technician found that the device would not stay in service mode.Troubleshooting identified a faulty pcb and once replaced, the device was recalibrated successfully.No further issues have been reported.H3 other text : see h10.

• Brand Name: JM-105 JAUNDICE METER
• Common Device Name: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 17367686
• Report Number: 2510954-2023-00013
• Device Sequence Number: 6118233
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230210(93)MU20105-24
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown