BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1964753 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01423
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE THERAPY CONNECTOR ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY CONNECTOR ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE MALFUNCTION TO BE A BROKEN LOW VOLTAGE PIN FROM THE PADDLES ASSEMBLY STUCK IN THE CORRESPONDING MATING CONNECTOR. HENCE, THE DEVICE WAS NOT ABLE TO DETECT THE PADDLES CONNECTION.

    Description of Event or Problem · 1

    A THIRD PARTY BIOMED REPORTED THAT THE DEVICE WAS NOT ABLE TO CHARGE ENERGY WITH THE PADDLES WHEN IT WAS ABLE TO DO SO VIA THE THERAPY CABLE. 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