BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2820745 · Received November 6, 2012

    Report

    Report Number
    3015876-2012-00822
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTION INFORMATION: "DATE OF EVENT" IN THE INITIAL MEDWATCH REPORT INDICATES: (B)(6) 2012. "DATE OF EVENT" IN THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(6) 2012. SUPPLEMENTAL INFORMATION: PHYSIO-CONTROL EVALUATED THE ELECTRONIC PATIENT RECORD FROM THE DEVICE AND DID OBSERVE MULTIPLE "LOW BATTERY" EVENTS AND MULTIPLE "ON/OFF" CYCLES; HOWEVER, PHYSIO WAS STILL UNABLE TO DUPLICATE THE REPORTED FAILURE DURING ADDITIONAL TESTING. THE CAUSE OF THE REPORTED FAILURE COULD NOT CONCLUSIVELY BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THE DEVICE POWERED ITSELF OFF SEVERAL TIMES WHILE THE PATIENT WAS BEING MONITORED. THERE WAS NO REPORT OF THE PATIENT NEEDING DEFIBRILLATION THERAPY THROUGHOUT THE EVENT. THE CUSTOMER DID NOT REPORT THAT THE PATIENT SUFFERED ANY ADVERSE EFFECT AS A RESULT OF THE REPORTED FAILURE. THE CUSTOMER INDICATED THAT THE BATTERIES BEING USED IN THE DEVICE WERE ONLY A FEW MONTHS OLD AND FOLLOWING THE EVENT, THE BATTERIES SHOWED TO HAVE A SUFFICIENT CHARGE ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1