BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 4180429 · Received October 17, 2014

    Report

    Report Number
    3015876-2014-01229
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 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

    PHYSIO-CONTROL FURTHER EXAMINED THE REMOVED THIRD PARTY USB DATA CABLE AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE +12 VOLT LINE WAS SHORTED OUT AT THE STRAIN RELIEF OF THE USB CONVERTER. WHILE TESTING THE CABLE WHEN THE SHORT WAS OBSERVED IT PREVENTED A TEST DEVICE FROM POWERING ON AND/OR CAUSED THE DEVICE TO POWER OFF BY ITSELF IF IT WAS ALREADY POWERED ON.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED ISSUE. IT WAS DETERMINED THAT A THIRD PARTY USB DATA CABLE THAT WAS PLUGGED INTO THE PHYSIO-CONTROL DEVICE CAUSED THE DEVICE TO NOT BOOT UP COMPLETELY. AFTER REPLACING THE FAULTY USB CABLE PHYSIO-CONTROL OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT WOULD NOT BOOT UP COMPLETELY. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663096 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1