BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8400 ST VOLUME VENTILATOR

    MDR report key: 5452 · Received April 9, 1993

    Report

    Report Number
    5452
    Event Type
    Malfunction
    Date Received
    April 9, 1993
    Date of Event
    January 26, 1993
    Report Date
    March 1, 1993
    Manufacturer
    BIRD PRODUCTS
    Product Code
    BYT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    VENTILATOR STOPPED SUDDENLY. NURSE GAVE MANUAL BREATHS WITH AMBU BAG UNTIL BACKUP VENTILATOR WAS PLACED BY RESPIRATORY THERAPISTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-DEC-92. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8400 ST VOLUME VENTILATOR ADULT VOLUME VENTILATOR BYT BIRD PRODUCTS 8400 ST

    Patients

    Seq Age Sex Outcome Treatment
    1 Other