BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3130373 · Received May 24, 2013

    Report

    Report Number
    3015876-2013-00439
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE AN ELECTRICALLY LEAKY FILTER, FL9, ON THE ANALOG PCB ASSEMBLY DUE TO IONIC CONTAMINATION ON THE BOARD SURFACE. THE EXCESSIVE CURRENT LEAKAGE DEPLETED THE INTERNAL HLC BATTERY.A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK) WHICH IS AN INDICATION THAT THIS DEVICE WOULD NOT HAVE SUFFICIENT POWER TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231592 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1