BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3843871 · Received June 2, 2014

    Report

    Report Number
    3015876-2014-00606
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, EXAMINED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE DEVICE WAS THEN SENT IN TO PHYSIO-CONTROL FOR FURTHER EVALUATION. PHYSIO EXAMINED THE CUSTOMER'S DEVICE BUT WAS ALSO UNABLE TO DUPLICATE, OR VERIFY, THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL POWER OFF BY ITSELF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321681 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1