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

Catalog Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2510954-2023-00014
• Device Sequence Number: 6712559
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)210409(93)MU20105-21
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: MU20105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown