BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLASSIC OVAL STRESS

    MDR report key: 280 · Received March 5, 1992

    Report

    Report Number
    280
    Event Type
    Death
    Date Received
    March 5, 1992
    Date of Event
    February 12, 1992
    Manufacturer
    CLASSIC MEDICAL PRODUCTS, INC.
    Product Code
    IKD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR DISPLAYED GRASS ONLY.CABLES & ELECTRODES CHANGED, BUT PICTURE DID NOT CHANGEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLASSIC OVAL STRESS DISPOSABLE ELECTRODE IKD CLASSIC MEDICAL PRODUCTS, INC. 07/02/93 7

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death