BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUAM UTERINE ACTIVITY MONITOR

    MDR report key: 32060 · Received April 17, 1996

    Report

    Report Number
    MW1008895
    Event Type
    Malfunction
    Date Received
    April 17, 1996
    Date of Event
    April 1, 1996
    Report Date
    April 11, 1996
    Manufacturer
    CORAM HEALTHCARE CORP.
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR WILL NOT CHARGE. IT WAS PLUGGED IN FOR 24 HRS AND WOULD NOT HOLD THE CHARGE. RPTR TESTED THE PUMP AND FOUND THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUAM UTERINE ACTIVITY MONITOR UTERINE ACTIVITY MONITOR KXO CORAM HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR