BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2990009 · Received March 5, 2013

    Report

    Report Number
    3015876-2013-00179
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. 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

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED PROBLEM; IT WAS UNABLE TO POWER ON AND DELIVER DEFIBRILLATION THERAPY. THE CAUSE FOR THE MALFUNCTION WAS DETERMINED TO BE FAILURE OF AN IC CHIP, DESIGNATOR U14. FAILURE OF THE CHIP RESULTED IN EXCESSIVE CURRENT LEAKAGE AND DEPLETED THE INTERNAL HLC BATTERIES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD ALL THREE (ATTENTION, CHARGE PAK AND WRENCH) ICONS ILLUMINATED WHEN IT WAS FIRST OPENED FROM THE BOX. THIS COULD BE AN INDICATIVE OF A DEVICE THAT WOULD NOT POWER ON TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94260 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1