BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 4151090 · Received October 8, 2014

    Report

    Report Number
    3015876-2014-01181
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE REPORTED FAILURE WAS DUE TO THE EXTERNAL THIRD PARTY USB DATA CABLE THAT WAS CONNECTED TO THE DEVICE. IT WAS OBSERVED THAT WHEN THE USB CABLE WAS SHOOK THE DEVICE TURNED OFF. WITH THE CABLE REMOVED, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CUSTOMER WILL REPLACE THE USB CABLE FROM THEIR INVENTORY. THE USB CABLE WAS NOT RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF WHEN THE DEVICE WAS SHOOK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633169 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1