BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2053391 · Received March 16, 2011

    Report

    Report Number
    3015876-2011-00242
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN FOR FURTHER 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

    DURING A SCHEDULED DEVICE INSPECTION TO UPGRADE SOFTWARE, PHYSIO-CONTROL SALES REP FOUND ALL THREE (ATTENTION, CHARGE PAK AND WRENCH) ICONS ILLUMINATED AND IT WOULD NOT 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