BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1003747 · Received February 22, 2008

    Report

    Report Number
    3015876-2008-00086
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DISPLAY WAS BLANK AND THE SYSTEM WOULD NOT TURN ON. PHYSIO REPLACED THE USER INTERFACE PCB ASSEMBLY AND THEN OBSERVED THAT IT WOULD PROPERLY POWER UP. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DISPLAY WAS BLANK AND THE DEVICE WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVED IN THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA