BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2080021 · Received April 6, 2011

    Report

    Report Number
    3015876-2011-00307
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL IS ANTICIPATING THE DEVICE RETURN FOR EVAL AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ALL THREE (ATTENTION, CHARGE PAK AND WRENCH) ICONS ILLUMINATED AND FAILED TO POWER ON. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA