BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3823827 · Received May 21, 2014

    Report

    Report Number
    3015876-2014-00580
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 30, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE PATIENT PARAMETER PCB ASSEMBLY. THEREAFTER PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED PATIENT PARAMETER PCB ASSEMBLY. IT WAS DETERMINED THAT INTEGRATED CIRCUIT CHIP, DESIGNATOR U1 WAS HEAT SENSITIVE AND CAUSED THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT A SERVICE INDICATOR WAS DISPLAYED ON THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD INTERMITTENTLY RESET ITSELF, OR LOCK UP, UPON POWERING ON. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303334 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1