BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3240529 · Received July 22, 2013

    Report

    Report Number
    3015876-2013-00640
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED DEVICE ISSUE. IT WAS OBSERVED THAT THE POWER SWITCH HAD TO BE PRESSED EXTRAORDINARLY HARD TO ACTIVATE. THE CUSTOMER WAS ADVISED THAT THIS DEVICE IS NO LONGER UNDER WARRANTY AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE FAILURE ANALYSIS CENTER FOR ADDITIONAL EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PRODUCT DEMONSTRATION, THEIR DEVICE WOULD NOT POWER ON. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE ON/OFF BUTTON HAD TO BE PRESSED EXTRAORDINARILY HARD TO ACTIVATE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340122 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1