BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 3170720 · Received June 14, 2013

    Report

    Report Number
    3015876-2013-00509
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CUSTOMER HAS ADVISED THAT THEY WILL BE TAKING THIS DEVICE OUT OF SERVICE FOR RETIREMENT. THE DEVICE WILL NOT BE REPAIRED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NORMAL EVALUATION, THE DEVICE WOULD ONLY DELIVER 100 JOULES DURING A 360 JOULE DEFIBRILLATION DELIVERY TEST. THIS WOULD NOT BE SUFFICIENT DEFIBRILLATION ENERGY IF USED ON A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271064 LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 10

    Patients

    Seq Age Sex Outcome Treatment
    1