BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACER ON A DEFIBRILLATOR

    MDR report key: 5035 · Received June 17, 1993

    Report

    Report Number
    5035
    Event Type
    Death
    Date Received
    June 17, 1993
    Date of Event
    March 24, 1993
    Report Date
    May 17, 1993
    Manufacturer
    PHYSIO-CONTROL
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    84 YEAR MALE PATIENT WAS BROUGHT INTO EMERGENCY ROOM WITH SEVERE CHEST PAIN AND WAS UNCONSCIOUS. A PACER WAS USED ON THIS PATIENT AND IT DID NOT FUNCTION. CLINICAL ENGINEER DETERMINED THAT CONNECTION BETWEEN PACER AND PADDLE WAS NOT PROPERLY CONNECTED. ONCE THIS WAS CORRECTED, THE PACER WORKEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. 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: EARLY EOL, RRT INDICATOR - END OF LIFE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACER ON A DEFIBRILLATOR N/A PHYSIO-CONTROL LP8 QUIK PACE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death