BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PEDIATRIC AMBU BAG

    MDR report key: 3020 · Received August 19, 1992

    Report

    Report Number
    3020
    Event Type
    Malfunction
    Date Received
    August 19, 1992
    Date of Event
    December 11, 1991
    Manufacturer
    MAPLESON-VITAL SIGNS, INC.
    Product Code
    KNE
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS MANUALLY BEING VENTILATED WITH VITAL SIGNS, INC. ANESTHESIA BAG. MANUAL VENTILATION WAS TO BE DECREASED. AS THIS WAS ADJUSTED THE RELIEF VALVE ON AMBU BAG FILLED WITH OXYGEN GAS. CHEST X-RAY PERFORMED. NO PATIENT INJURY DELETEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PEDIATRIC AMBU BAG KNE MAPLESON-VITAL SIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other