BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 15 · Received March 10, 1992

    Report

    Report Number
    15
    Event Type
    Death
    Date Received
    March 10, 1992
    Date of Event
    February 17, 1992
    Report Date
    February 28, 1992
    Manufacturer
    LIFE CARE
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    VENTILATOR BECAME DETACHED FROM PATIENT. TUBING RESTED ON PATIENT BODY AND PRESSURE ALARM DID NOT SOUND. PATIENT WAS ALERT BUT DID NOT USE CALL BELL AND EXPIRED. VENTILATOR WAS TESTED AND NO MALFUNCTION IDENTIFIED. PRESSURE OF TUBING ON PATIENT'S CHEST WAS SUBSTANTIAL ENOUGH TO PREVENT ALARM FROM SOUNDINGDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, OTHER, OTHER, INVALID DATA, INVALID DATA. RESULTS OF EVALUATION: OTHER. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A VENTILATOR CBK LIFE CARE PLV-102 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death