BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 4152770 · Received October 8, 2014

    Report

    Report Number
    3015876-2014-01187
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS ABLE TO VERIFY THE REPORTED FAILURE. PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THIS DEVICE IS NO LONGER SUPPORTED AND PARTS ARE NOT AVAILABLE. THE DEVICE WAS RETURNED TO THE CUSTOMER UNREPAIRED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CONTRACT EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT CHARGE DEFIBRILLATION ENERGY PAST 100 JOULES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631232 LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 10

    Patients

    Seq Age Sex Outcome Treatment
    1