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

Catalog Number MU20105

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.

Manufacturer Narrative

A complaint was received regarding the draeger jm105 jaundice meter was providing inconsistent/low readings.Additional information was provided; however, the customer provided only two measurement which is not enough to perform data analysis.The response to the clinical questions confirmed the meter was being used correctly.Therefore, the reported low reading could not be verified.The meter was returned to the dreager medical repair center and no malfunction was identified.As a precautionary measure the sensor set was replaced, and the meter was calibrated and returned to the customer.Root cause of the low readings could not be determined.For customer satisfaction, the meter was replaced to resolve the issue.No further issues have been reported.

Event Description

It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.

• Brand Name: JM-105 JAUNDICE METER
• Type of Device: JAUNDICE METER/BILIRUBINOMETER
• 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 ; 2156602400
• MDR Report Key: 17546187
• MDR Text Key: 321582959
• Report Number: 2510954-2023-00014
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)210409(93)MU20105-21
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: MU20105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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
• Treatment: NA.; NA.