BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2091278 · Received May 4, 2011

    Report

    Report Number
    3015876-2011-00363
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE. FOLLOW UP WITH THE CUSTOMER FOUND THAT THE BIOMED DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE THE THERAPY CABLE. THE BIOMED REPLACED THE THERAPY CABLE ASSEMBLY AND CONFIRMED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO SERVICE FOR USE. THE REMOVED THERAPY CABLE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING DAILY INSPECTION, THE CUSTOMER NURSE REPORTED THAT THE DEVICE GAVE THE "ABNORMAL ENERGY DELIVERED" MESSAGE WHILE CHARGING AND SHOCKING INTO A TEST PLUG 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