BEUDAMED
    FDA Adverse Event Death Summary report: N

    1220908-2001-01522

    MDR report key: 359833 · Received October 31, 2001

    Report

    Report Number
    1220908-2001-01522
    Event Type
    Death
    Date Received
    October 31, 2001
    Date of Event
    October 2, 2001
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE CLINICIANS WERE ANALYZING THE HEART RHYTHM OF A PATIENT WHO WAS IN CARDIAC ARREST, BUT THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT TO A VENTRICULAR FIBRILLATION HEART RHYTHM. IN ADDITION, THE DEVICE GAVE "ECG TO SMALL", "ECG TOO LARGE" AND "NOISY ECG" MESSAGES. THE CLINICIANS THEN SWITCHED THE DEVICE TO MANUAL MODE AND DELIVERED A 200 JOULE SHOCK TO THE PATIENT. THE CLINICIANS THEN SWITCHED THE DEVICE BACK TO AED MODE AND ANALYZED THE PATIENT'S HEART RHYTHM, BUT THE DEVICE DISPLAYED THE SAME MESSAGES. THE COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, BUT THAT THE PATIENT OUTCOME WAS NOT AS A RESULT OF THE REPORTED MALFUNCTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death