BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIO CONTROL

    MDR report key: 292114 · Received August 8, 2000

    Report

    Report Number
    MW4002817
    Event Type
    Malfunction
    Date Received
    August 8, 2000
    Date of Event
    July 20, 2000
    Report Date
    July 31, 2000
    Manufacturer
    PHYSIO CONTROL
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF FAST PATCH CONNECTOR POST BROKE OFF INSIDE CONNECTOR OF PHYSIO CONTROL LIFEPAK 10. THIS PREVENTED USER FROM GETTING SOLID CONNECTION. ALTHOUGH SOME ARCING OCCURRED WITHIN CONNECTOR, PT WAS REVIVED WITHOUT FURTHER INTERVENTION. CONCERN IS THAT BAD CONNECTION COULD RESULT IN ADVERSE EVENT UNDER DIFFERENT CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL DEFIBRILLATOR FAST-PATCH MLN PHYSIO CONTROL QUANTUM EDGE FAST-PATCH NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR