BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES BIPHASIC

    MDR report key: 2537629 · Received April 9, 2012

    Report

    Report Number
    1220908-2012-00792
    Event Type
    Death
    Date Received
    April 9, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 20, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    PMA / PMN Number
    K990762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: DATE OF THIS REPORT: (B)(4) 2012. COMMON DEVICE NAME: DEFIBRILLATOR, EXTERNAL. MODEL #: M SERIES. DEVICE AVAILABLE FOR EVALUATION: YES. (B)(6).

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) FEMALE PATIENT, THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATED THAT SUBSEQUENT TESTING DID NOT DUPLICATE THE REPORTED MALFUNCTION. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: TITLE: XXXXX. EVENT DESC: TEXT TAKEN FROM EMS REPORT: "DURING PATIENT CARE DEFIBRILLATION WAS ATTEMPTED WITH NO SHOCK DELIVERED. PATIENT WAS IN FINE V-FIB AND THEN ASYSTOLE. NO FURTHER ATTEMPTS WERE MADE. UPON ARRIVAL TO THE HOSPITAL, THE DEVICE WAS TAKEN OUT OF SERVICE. ATTEMPTED TO TEST SHOCK AND WAS NOT ABLE TO DELIVER THE SHOCK. THE BATTERY WAS NOT LOW, AND THERE WAS NO LOW BATTERY INDICATOR ON. CLINICAL ENGINEERING WAS NOTIFIED AND THE DEVICE WAS PICKED UP." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TOO DELIVER A SHOCK TO A PATIENT IN V-FIB. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES BIPHASIC DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death