BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4182354 · Received October 17, 2014

    Report

    Report Number
    3015876-2014-01232
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 22, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED DEVICE ISSUE. IT WAS OBSERVED THAT THE DEVICE HAD LOGGED SOME EVENT CODES WHICH DID NOT APPEAR TO BE RELATED TO THE REPORTED POWER/LOCK UP ISSUE. PHYSIO THEN RECOMMENDED REPAIR FOR THE NON CRITICAL EVENT CODES BUT THE CUSTOMER DECIDED TO DECLINE REPAIRS DUE TO COSTS. THE EVENT CODES WERE CLEARED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED POWER/LOCK UP ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, DIRECTOR OF CLINICAL TECHNOLOGIES, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THEIR DEVICE POWERED OFF BY ITSELF. THE PATIENT, A (B)(6) YEAR-OLD FEMALE, HAD BEEN DIAGNOSED AS BRADYCARDIC (HEART RATE WAS APPROXIMATELY 20 BPM) AND HAD BEEN CONNECTED TO THE PHYSIO DEVICE TO RECEIVE EXTERNAL PACING THERAPY. DURING THE EVENT, THE PATIENT WAS ALSO CONNECTED TO AN EXTERNAL BEDSIDE MONITOR WHICH ALARMED TO NOTIFY THE HOSPITAL STAFF THAT THE PATIENT WAS ASYSTOLIC. UPON ENTERING THE ROOM, THE HOSPITAL STAFF OBSERVED THAT THE PHYSIO DEVICE HAD STOPPED PACING THE PATIENT, COMPLETED A SELF-TEST, AND THEN POWERED OFF BY ITSELF. A BACKUP DEVICE WAS OBTAINED AND USED TO CONTINUE PACING THE PATIENT. THE PATIENT SURVIVED THE EVENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT THAT WERE REPORTED AS A RESULT OF THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, THE FACILITY BIOMEDICAL ENGINEER OBSERVED THAT IT WOULD NOT COMPLETE THE BOOT UP CYCLE AND APPEARED TO BE LOCKED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661453 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR