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

Model Number MU26222

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

Draeger contacted the customer who stated the device was repaired by a 3rd party, the sensor had failed.H3: see h10.

Event Description

At 9:15am on 30 march 2023, the device passed the pre use check.During use, the user found the measured value was abnormal, changed to other device to measure again.The user stopped use the device and reported it to the biomedical technician.No adverse patient impact was reported.

• Brand Name: JM-105 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 SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 16872993
• MDR Text Key: 314657655
• Report Number: 2510954-2023-00004
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K133175
• 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: MU26222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• 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