BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1883870 · Received October 22, 2010

    Report

    Report Number
    3015876-2010-01174
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE TO OPERATE ON AC OR DC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND VERIFIED THE REPORTED FAILURE. HOWEVER, ADD'L EXTENSIVE TESTING WAS UNABLE TO FURTHER DETERMINE A CONCLUSIVE COMPONENT CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    DURING A MORNING CHECK, THE FACILITY NURSE FOUND THAT THE DEVICE WOULD NOT TURN ON AC OR DC POWER. THERE WAS NO PT USE ASSOCIATED WITH THE 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