BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    MDR report key: 3903052 · Received June 30, 2014

    Report

    Report Number
    3015876-2014-00742
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON THE DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. ADDITIONALLY, WHEN POWERED ON, THE DEVICE ALARMED INSTEAD OF PROVIDING VOICE PROMPTS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381161 LIFEPAK EXPRESS(R) DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC EXPRESS

    Patients

    Seq Age Sex Outcome Treatment
    1