BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1014000 · Received March 13, 2008

    Report

    Report Number
    3015876-2008-00175
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WOULD NOT POWER UP ON AC POWER. THE POWER SUPPLY ASSEMBLY WAS REPLACED, THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    FOUND DURING DAILY TESTING. ACCORDING TO THE REPORTER, THE DEVICE HAD NO AC OPERATION. NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

    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