MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS INC JAUNDICE JM105; JAUNDICE METER/BILIRUBINOMETER

Catalog Number MU20105

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that the jm-105 provided low values.No adverse patient impact was reported.

Manufacturer Narrative

The investigation was started; results will be provided in a follow up-report.

• Brand Name: JAUNDICE JM105
• Type of Device: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784828529
• MDR Report Key: 18777815
• MDR Text Key: 337311392
• Report Number: 2510954-2024-00004
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial

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 Catalogue Number: MU20105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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
• Patient Age: 4 DA
• Patient Race: White