BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3023591 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00240
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT 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 HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. AFTER SEVERAL FOLLOW-UP ATTEMPTS WITH THE CUSTOMER, PHYSIO WAS UNABLE TO CONFIRM IF THIS PARTICULAR DEVICE WAS REMOVED FROM SERVICE.THE CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED ALL THREE (ATTENTION, CHARGE-PAK AND WRENCH) ICONS. THIS IS INDICATIVE OF A DEVICE THAT WILL NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127237 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1