BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2842475 · Received November 21, 2012

    Report

    Report Number
    3015876-2012-00851
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR REPLICATE THE REPORTED PROBLEM. ONE OF THE BATTERY POSTS WAS LOOSE BUT PROPER DEVICE OPERATION OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED. THE THIRD PARTY SERVICE AGENT EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED PROBLEM. THE SERVICE AGENT DID OBSERVED A BATTERY PIN TO BE LOOSE. THE SERVICE AGENT TIGHTENED THE BATTERY PIN AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR REPLICATE THE REPORTED PROBLEM. ONE OF THE BATTERY POSTS WAS LOOSE BUT PROPER DEVICE OPERATION OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY TURNS ITSELF OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    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