BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4090620 · Received September 15, 2014

    Report

    Report Number
    3015876-2014-01085
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS CLARIFIED WITH PHYSIO-CONTROL THAT THEIR INITIALLY REPORTED DEVICE ISSUE REGARDING A FAILURE TO DELIVER DEFIBRILLATION ENERGY WAS REPORTED INCORRECTLY. THE DEVICE NEVER FAILED TO DELIVER DEFIBRILLATION ENERGY AND ONLY WAS EXHIBITING AN ISSUE PASSING THE USER TEST. PHYSIO-CONTROL DID EVALUATE THE DEVICE AND WAS UNABLE TO VERIFY ANY FAILURE TO DELIVER DEFIBRILLATION ENERGY. PHYSIO-CONTROL PERFORMED UNRELATED REPAIRS AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NOT PASS ITS USER TEST AND ALSO NO LONGER HAD THE ABILITY 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
    570411 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1