BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1845036 · Received September 13, 2010

    Report

    Report Number
    3015876-2010-01017
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE SYSTEM/MEMORY PCB 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 SYSTEM/MEMORY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND FOUND THE CAUSE OF THE OBSERVED FAILURE TO BE A POOR CONNECTION BETWEEN THE TWO PCB'S. SEVERAL PINS OF J3. THE PCB-MOUNTED JACK CONNECTOR ON THE SYSTEM PCB, WERE DAMAGED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE SCREEN WENT BLANK WHILE PACING A PATIENT AND RETURNED. THE REPORTED EVENT HAD NO ADVERSE EFFECTS ON THE PATIENT AND THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED. FURTHER INVESTIGATION FOLLOWING DEVICE EVALUATION BY PHYSIO-CONTROL FOUND THAT THE DEVICE WOULD RESET WITH THE LIGHTEST TOUCH. THE DEVICE MIGHT NOT BE AVAILABLE TO PROVIDE DEFIBRILLATION THERAPY IN THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK