BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC EXTERNAL DEFIBRILLATOR

    MDR report key: 34915 · Received July 22, 1996

    Report

    Report Number
    34915
    Event Type
    Malfunction
    Date Received
    July 22, 1996
    Date of Event
    July 15, 1996
    Report Date
    July 18, 1996
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/15/96, THE EMT SVC FROM THE MED CTR WAS SUMMONED TO A CARDIAC ARREST. FOLLOWING THEIR PROTOCOL THEY ATTACHED THE CO AED TO THE PT. THEY GOT AN INITIAL RHYTHM OF VENTRICULAR FIBRILLATION ON THE OSCILLOSCOPE. THEY ATTEMPTED TO ANALYZE BUT GOT A CHECK ELECTRODE MESSAGE. WITH HAND PRESSURE ON THE ELECTRODE PADS, THEY AGAIN GOT A BRIEF RHYTHM. HOWEVER, THEY COULD NOT MAINTAIN ELECTRODE CONTACT LONG ENOUGH TO ALLOW THE MACHINE TO ANALYZE. THE ELECTRODE PADS WERE CHANGED. THERE WAS NO IMPROVEMENT IN RHYTHM DETECTION. THE EMT'S COULD NOT DEFIBRILLATE ON SCENE BECAUSE OF THIS MALFUNCTION. FOLLOWING THE CONCLUSION OF THE RESUSCITATION EFFORT THE FOLLOWING WERE CHECKED: THE OUTDATES ON THE ELECTRODE PADS WAS 7/97. PLACING A NEW SET OF PADS ON A VOLUNTEER AND USING THE SAME MONITOR, CABLE, AND PERSONNEL, THE PROBLEM COULD NOT BE REPRODUCED. CONVERSATION WITH THE MFR LEAD TO NO OBVIOUS CONCLUSION. THE UNIT WAS TAKEN OUT OF SVC AND RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC EXTERNAL DEFIBRILLATOR AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ LAERDAL MEDICAL CORP. 3000 QR

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other