BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3241580 · Received July 22, 2013

    Report

    Report Number
    3015876-2013-00641
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    February 8, 2013
    Report Date
    June 28, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EXAMINED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U28. IC CHIP U28 SHOULD HAVE HAD 5 VOLTS OF OUTPUT; HOWEVER, IT WOULD ONLY GET TO 3.11 VOLTS. THIS LED TO THE DEVICE CONTINUALLY RESETTING/REBOOTING ITSELF. DURING TESTING, PROPER OPERATION WAS OBSERVED WHEN U28 WAS REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO THEN REPLACED THE SYSTEM PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE REQUIRED SERVICE. NO FURTHER DETAILS WERE PROVIDED AT THAT TIME. UPON EXAMINATION OF THE CUSTOMER'S DEVICE, PHYSIO OBSERVED THAT THE UNIT WOULD CONTINUALLY RECYCLE POWER (ON, OFF, ON, OFF, ETCETERA) BY ITSELF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340939 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1