BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 4911163 · Received July 13, 2015

    Report

    Report Number
    3015876-2015-00812
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 15, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K122600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE BUT COULD NOT REPRODUCE THE REPORTED ISSUE ANYMORE. THE DEVICE COULD BE POWERED ON AND WOULD CHARGE AND SHOCK DEFIBRILLATION ENERGY. THE DEVICE WAS OPENED AND INSPECTED INTERNALLY, BUT NO DISCREPANCIES COULD BE OBSERVED. THE PCB ASSEMBLIES WERE HEATED AND COOLED WHILE POWERING ON AND OFF THE DEVICE, BUT THE DEVICE CONTINUED TO FUNCTION CORRECTLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE BATTERY WAS TESTED WITHOUT OBSERVING ANY DISCREPANCIES. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD FAILED ITS MONTHLY SELF-TEST. DURING DEVICE EVALUATION, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT BOOT-UP COMPLETELY. THERE WAS NO PATIENT USE REPORTED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452553 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1