BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1965244 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01426
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND RECOMMENDED REPLACEMENT OF THE RELAY ASSEMBLY; HOWEVER, THE CUSTOMER DECLINED REPAIR AND CONFIRMED THAT THE DEVICE WILL BE RETIRED FROM USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER FINDING THE DEVICE IN STORAGE, IT FAILED TO DELIVER THERAPY DURING TESTING. THE REPORTED FAILURE OCCURRED ONE TIME AND THE DEVICE WAS ABLE TO DELIVER THERAPY NORMALLY AFTER THE FAILURE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA