BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JM-103 JAUNDICE METER

    MDR report key: 16861217 · Received May 3, 2023

    Report

    Report Number
    2510954-2023-00003
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    March 11, 2023
    Report Date
    April 24, 2023
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Product Code
    MQM
    PMA / PMN Number
    K042522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DRAEGER CONTACTED THE CUSTOMER WHO STATED THE DEVICE WAS REPAIRED BY A 3RD PARTY. POOR ELECTRICAL CONTACT INSIDE THE DEVICE WAS IDENTIFIED AS THE CAUSE, THE CONTACT WAS RE-SOLDERED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    THE VALUE MEASURED BY JM103 WAS 289-267-259 MOL/L, REACHED THE THRESHOLD OF PHOTOTHERAPY 248 MOL/L, SO GAVE THE TREATMENT WITH STANDARD PHOTOTHERAPY. HOWEVER, THE BLOOD VALUE WAS 313.27 MOL/L, WHICH WAS CLOSE TO THE THRESHOLD OF BLOOD EXCHANGE (359.1 MOL/L), SO ENHANCED THE TREATMENT OF PHOTOTHERAPY. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533767 JM-103 JAUNDICE METER JAUNDICE METER/BILIRUBINOMETER MQM DRAEGER MEDICAL INFANT CARE, INC. MU26219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown