BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2963851 · Received February 15, 2013

    Report

    Report Number
    3015876-2013-00121
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    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

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL OBSERVED THAT THE DEVICE SHOWED ALL THREE INDICATORS (SERVICE INDICATOR, ATTENTION INDICATOR AND CHARGE-PAK INDICATOR) AND THAT THE CHARGE-PAK HAD PASSED ITS EXPIRATION DATE. PHYSIO-CONTROL REPLACED THE CHARGE-PAK AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AFTER REPLACEMENT OF THE CHARGE-PAK THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE REPLACEMENT OF THE CHARGE-PAK IS THE RESPONSIBILITY OF THE CUSTOMER. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SALES REPRESENTATIVE THAT THE CUSTOMER'S DEVICE SHOWED THE BATTERY ICO, ATTENTION ICON AND SERVICE ICON IN THE DEVICE'S READINESS DISPLAY. WITH ALL THREE ICONS SHOWING, THE DEVICE WOULD NOT HAVE ENOUGH POWER TO SUFFICIENTLY PROVIDE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69032 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1