BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1941014 · Received December 8, 2010

    Report

    Report Number
    3015876-2010-01351
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    September 10, 2018
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Removal / Correction Number
    3015876-02/08/2013-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL IS ANTICIPATING THE DEVICE RETURN TO THE MANUFACTURING FACILITY AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL 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 WAS DISPLAYING ALL THREE (CHARGE PAK, ATTENTION AND WRENCH) ICONS. THIS IS AN INDICATIVE OF A DEVICE THAT MIGHT 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 Unknown