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 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility report states that the device is back in use after having been repaired by the manufacturer.In fact, the device is not under a draeger service contract and, the hospital did not involve the local dräger s&s organization into any follow-up measures.A potential explanation would be that a third-party service provider did the examination and repair.This does not allow a case-specific evaluation by dräger and, no reliable conclusion in regard to the exact root cause can be made.The device was manufactured in 2012 and, the state of preventive maintenance is not known.The ifu clearly describes that preventive maintenance and calibration shall be done in annual intervals.It cannot be excluded for the particular case that calibration was overdue already and that this has lead to measurement inaccuracy.Other explanations may apply as well; a differentiation is not possible due to lack of information.H3 other text : device not available for evaluation.

Event Description

It was reported that the transcutaneous bilirubin value measured by the jm-105 was low in comparison to a blood gas measurement.As per report, this did not lead to delay in therapy for the involved patient.

• 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: 18397122
• MDR Text Key: 331364364
• Report Number: 1220063-2023-00055
• 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: 12/27/2023

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 Catalogue Number: MU26219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2012
• 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