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

Model Number MU20105

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.

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
• Type of Device: 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
• MDR Text Key: 319766759
• Report Number: 2510954-2023-00013
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230210(93)MU20105-24
• Combination Product (y/n): N
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1