MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JM-105; TRANSCUTANEOUS BILIRUBINMETER

Catalog Number MU26219

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Jaundice (2187)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

It was reported that the readings of the bilirubinmeter were found to be low.It was concluded that this is likely a measurement error whereupon a blood gas analysis was initiated.There was no detail in the report which would reasonably suggest that this has led to a delay in treatment for the particular case or to any other consequences for the patient.

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization into remedy of the issue.Dräger has contacted the hospital and asked for further information but not yet received a response.The device was manufactured in 2017 and is not under a service contract; the responsibility for the recommended regular checks and the required recalibrations is thus with the owner/operator.It cannot be excluded that lack of preventive service and maintenance has caused or contributed to the event.Other explanations may apply as well; a differentiation is not possible due to lack of information.

• Brand Name: JM-105
• Type of Device: TRANSCUTANEOUS BILIRUBINMETER
• 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 ; 9784470587
• MDR Report Key: 18516017
• MDR Text Key: 333351803
• Report Number: 1220063-2024-00006
• 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: 01/16/2024

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 Catalogue Number: MU26219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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