MAUDE Adverse Event Report: DRAEGER MEDICAL INFANT CARE, INC. JM-103 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER

Model Number MU26219

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 03/11/2023

Event Type  malfunction  

Event Description

The value measured by jm103 was 289-267-259 mol/l, reached the threshold of phototherapy 248 mol/l, so gave the treatment with standard phototherapy.However, the blood value was 313.27 mol/l, which was close to the threshold of blood exchange (359.1 mol/l), so enhanced the treatment of phototherapy.No adverse patient impact was reported.

Manufacturer Narrative

Draeger contacted the customer who stated the device was repaired by a 3rd party.Poor electrical contact inside the device was identified as the cause, the contact was re-soldered to resolve the issue.

• Brand Name: JM-103 JAUNDICE METER
• Type of Device: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 16861217
• MDR Text Key: 314619226
• Report Number: 2510954-2023-00003
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K042522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2023

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: MU26219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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