BEUDAMED
    FDA Adverse Event Death Summary report: N

    E

    MDR report key: 474 · Received March 26, 1992

    Report

    Report Number
    474
    Event Type
    Death
    Date Received
    March 26, 1992
    Date of Event
    February 6, 1992
    Report Date
    March 10, 1992
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT ENTERED THE E.R. PER AMBULANCE PULSELESS AND NON-BREATHING. PUPILS WERE FIXED AND DIALATED. CPR WAS IN PROCESS. A CODE 4 WAS STARTED IMMEDIATELY ON ARRIVAL. APPROXIMATELY 15 MINUTES INTO RESUSCITATION, A NON-INVASIVE TEMPORARY PACEMAKER WAS APPLIED. THERE WAS NO VISABLE SIGNS OF DISCHARGE AND NO PACER SPIKES PRESENT ON EKG TRACING. THE UNIT WAS IMMEDIATELY DISCONNECTEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-MAY-90. 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: ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E NON-INVASIVE TEMPORARY PACEMAKER DRO ZMI CORPORATION NTP 1000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death