BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1883876 · Received October 22, 2010

    Report

    Report Number
    3015876-2010-01161
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS RECEIVED THE DEVICE AND IS CURRENTLY REPAIRING IT. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    DURING A MORNING INSPECTION, IT WAS REPORTED THAT THE DEVICE THERAPY CONNECTOR HAD BROKEN PINS. THE DEVICE WAS NOT ABLE TO PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THE FACILITY BIOMED REPLACED THE THERAPY CONNECTOR ASSEMBLY TO RESOLVE THE PROBLEM. HOWEVER, THE DEVICE ILLUMINATED THE SERVICE LIGHT AND LOGGED EVENT CODES IN THE MEMORY WHEN IT WAS REASSEMBLED. 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