BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3940967 · Received July 17, 2014

    Report

    Report Number
    3015876-2014-00818
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND HAS VERIFIED THE REPORTED INTERMITTENT FAILURE. AS A PRECAUTION, PHYSIO HAS REPLACED THE SYSTEM PCB ASSEMBLY. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE REMOVED EXTERNAL USB DATA CABLE WAS FURTHER EVALUATED BY PHYSIO-CONTROL. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE THAT THE +12 VOLT LINE WAS SHORTED OUT AT THE STRAIN RELIEF.

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL INVESTIGATION, PHYSIO-CONTROL CONFIRMED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A THIRD PARTY USB DATA CABLE. WHEN THIS CABLE IS PLUGGED INTO THE DEVICE, IT CAUSED THE DEVICE TO NOT HAVE THE ABILITY TO BOOT UP PROPERLY WITHOUT THE CABLE PLUGGED INTO THE DEVICE, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE HAS SINCE BEEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS INTERMITTENTLY NOT BOOTING UP COMPLETELY. THIS WAS OBSERVED DURING TESTING AND THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418999 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1