BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3863752 · Received June 10, 2014

    Report

    Report Number
    3015876-2014-00641
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH A REPLACEMENT DEVICE. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER, BOTH VIA PHONE AND IN WRITING, ABOUT RETURNING THE DEVICE FOR EVALUATION AND NO RESPONSE APPEARS TO BE FORTHCOMING. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THEIR DEVICE TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. THE DEVICE'S DISPLAY SHOWED "OK" AND THERE WAS NO EVIDENCE IN THE DOWNLOADED MEMORY THAT ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH) WERE EVER PRESENT ON THE DISPLAY. THE UNIT WOULD POWER ON, CHARGE AND DEFIBRILLATE WHEN PROMPTED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH). THE ILLUMINATION OF ALL THREE ICONS INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340575 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1