BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2981892 · Received February 28, 2013

    Report

    Report Number
    3015876-2013-00158
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL OBSERVED THAT THE THERAPY CONNECTOR ASSEMBLY WAS NOT CONNECTED TO THE THERAPY PCB ASSEMBLY. PHYSIO-CONTROL RECONNECTED THE THERAPY CONNECTOR ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT, DURING A TRAINING SESSION, THE CUSTOMER'S LOANER DEVICE DISPLAYED THE MESSAGE "CONNECT CABLE" AFTER THE THERAPY CABLE HAD BEEN CONNECTED TO THE DEVICE. THEREFORE THE DEVICE MAY NOT PROVIDE DEFIBRILLATION THERAPY WHEN REQUIRED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87507 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1