BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3071597 · Received April 22, 2013

    Report

    Report Number
    3015876-2013-00325
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS ATTEMPTED TO RECEIVE THE DEVICE FROM THE CUSTOMER FOR EVALUATION, BUT HAS BEEN UNSUCCESSFUL. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH) WHICH INDICATES THE DEVICE WOULD NOT HAVE SUFFICIENT POWER FOR DEFIBRILLATION, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172332 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1