BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 6460453 · Received April 5, 2017

    Report

    Report Number
    3015876-2017-00416
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 5, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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

    DEVICE MANUFACTURE DATE, OF THE INITIAL MEDWATCH REPORT INDICATES: 01/22/2003. DEVICE MANUFACTURE DATE, OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 01/24/2003.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL WAS ADVISED THAT THE CUSTOMER'S DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN RETIRED FROM SERVICE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK) AND WOULD NO LONGER POWER ON.  THE DEVICE WOULD NOT BE IN A USABLE STATE FOR A PATIENT EVENT, IF NEEDED.  THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241606 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1