BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3203375 · Received July 2, 2013

    Report

    Report Number
    3015876-2013-00573
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THEY HAVE REPLACED THE THERAPY CONNECTOR ASSEMBLY ON THE DEVICE AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO SERVICE FOR USE. THE DEVICE WAS NOT RETURNED TO PHYSIO FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE HAD A BROKEN PIN FROM THE HARD PADDLES ASSEMBLY BROKEN OFF INTO THE THERAPY CONNECTOR ASSEMBLY ON THE DEVICE. THIS BROKEN PIN WOULD NOT ALLOW THE CONNECTION OF ANY ADDITIONAL HARD PADDLES ASSEMBLY OR THERAPY CABLE ASSEMBLY AND WOULD LIKELY NOT ALLOW THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302432 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1