BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2820341 · Received November 6, 2012

    Report

    Report Number
    3015876-2012-00820
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 8, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE USER INTERFACE PCB ASSEMBLY TO THE PCB STACK. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE WAS SHOWING THE IMAGE ON THE DISPLAY AS BACKWARDS. AFTER PHYSIO-CONTROL EVALUATED THE DEVICE, IT WAS OBSERVED THAT THE DISPLAY WAS NOT FUNCTIONING AND ALSO, THE DEVICE WOULD NOT BOOT UP COMPLETELY. THE DEVICE WOULD NOT BE ABLE TO BE USED ON A PATIENT IN THIS CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1