BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU BABY RESUSCITATOR

    MDR report key: 465 · Received April 15, 1992

    Report

    Report Number
    465
    Event Type
    Malfunction
    Date Received
    April 15, 1992
    Date of Event
    March 19, 1992
    Report Date
    March 30, 1992
    Manufacturer
    AMBU, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 3/19/92 WHILE ATTEMPTING TO AMBU AN INFANT WITH RESPIRATORY PROBLEMS THE AMBU BAG FELL APART AS STATED BY RN. WHEN CONNECTED TO O-2 CONTINUED TO POP APART. THIS MAY HAVE BEEN DUE TO THE AGE OF BAG OR THE DESIGN. AT TIME IT APPEARS THAT THE BODY OF THE BAG TENDS TO SKIP OFF THE ONE-WAY VALVE ASSEMBLY. DEFECTIVE PRODUCT WAS REPLACED WITH PROPER WORKING ONE PURITAN BENNETT DISPOSABLE RESUSCITATOR.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU BABY RESUSCITATOR BABY RESUSCITATOR BTL AMBU, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Other