BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3201750 · Received July 2, 2013

    Report

    Report Number
    3015876-2013-00565
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    THE DEVICE WAS NOT EVALUATED BY PHYSIO-CONTROL. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS RETURNED TO PHYSIO-CONTROL. HOWEVER, PHYSIO-CONTROL DID NOT RECEIVE THE DEVICE. THEREFORE PHYSIO-CONTROL IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ALL THREE ICONS (SERVICE WRENCH, ATTENTION AND CHARGE PAK) ILLUMINATED IN THE READINESS DISPLAY. THEREFORE THE DEVICE WOULD NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300730 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1