BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL NTP

    MDR report key: 1200 · Received August 25, 1992

    Report

    Report Number
    1200
    Event Type
    Death
    Date Received
    August 25, 1992
    Date of Event
    July 30, 1992
    Report Date
    August 7, 1992
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING THE "CARDIAC ARREST" PROCEDURES, PHYSICIAN REQUESTED THE USE OF THE ZOLL EXTERNAL PACER. IT WAS APPLIED PER PROTOCOL, AND GRADUALLY INCREASED THE POWER. WHEN POWER ROSE TO 140, THERE WAS STILL NO CAPTURE. IF THE CORD WAS HELD IN A CERTAIN POSITION, IT WOULD OCCASIONALLY CAPTUREDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN - INADEQUATE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL NTP DRO ZMI CORPORATION NTP 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death