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

Catalog Number MU26222

Device Problem False Negative Result (1225)

Patient Problem Jaundice (2187)

Event Date 11/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : device not available for evaluation.

Event Description

It was reported that the patient showed signs of bilirubinea but the measurement taken with the jm-105 indicated no need for phototherapy.A blood test performed later-on indeed showed an increased bilirubin level making phototherapy necessary.

Manufacturer Narrative

We have become aware this is not our product and we have notified (b)(6) of the case.Several attempts were made to gain additional information regarding the event.The customer confirmed the event occurred but stated that no further information was available.The customer uses a 3rd party to service the device.Therefore, no further investigation is possible and root cause of the reported issue cannot be determined.

Event Description

It was reported that the patient showed signs of bilirubinea but the measurement taken with the jm-105 indicated no need for phototherapy.A blood test performed later-on indeed showed an increased bilirubin level making phototherapy necessary.

• 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 23542 ; GM 23542
• Manufacturer Contact: 3135 quarry road; telford, PA 23542 ; 2156602400
• MDR Report Key: 18397120
• MDR Text Key: 331691252
• Report Number: 1220063-2023-00057
• 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,Followup
• Report Date: 03/22/2024

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: MU26222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/22/2024
• 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