BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2061384 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00254
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 18, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THE REPORTED INTERMITTENT FAILURE TO POWER ON AND LOSS OF POWER. PHYSIO DETERMINED THE CAUSE OF THE FAILURE TO BE A SHORTED OSITECH SERIAL/USB CABLE. PHYSIO-CONTROL PROVIDED THE CUSTOMER A REPLACEMENT OSITECH SERIAL/USB CABLE. PHYSIO CONFIRMED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND RETURNED IT TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    DURING THE DEVICE USE WITH A PT, IT WAS REPORTED THAT THE DEVICE FAILED TO POWER ON WITH FULLY CHARGED BATTERIES. THE USER CHANGED THE BATTERIES BUT THE ISSUE PERSISTED. ONCE THE PT WAS TRANSPORTED TO THE ER, THE DEVICE WAS REPORTED TO POWER ON BUT LOST POWER AS THE USER ATTEMPTED TO UPLOAD VITALS. THERE WERE NO ADVERSE EFFECTS REPORTED AS THE RESULT OF THE DEVICE USE. THERE WAS NO FURTHER ADDITIONAL INFO ON THE EVENT OR THE PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK