BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIRK MEDICAL SYSTEMS

    MDR report key: 230061 · Received June 24, 1999

    Report

    Report Number
    MW1016657
    Event Type
    Injury
    Date Received
    June 24, 1999
    Date of Event
    June 18, 1999
    Report Date
    June 23, 1999
    Manufacturer
    KIRK SPECIALTY SYSTEMS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    KSS DISPOSABLE AMBU BAG HAD CATASTROPHIC FAILURE DURING URGENT/EMERGENT INTUBATION. BAG FAILED TO PRESSURIZE, WOULD NOT DELIVER VOLUME TO PT. INCIDENT REPORT STATES "PRESSURE ESCAPED VIA A SIDE PORT WITH FAULTY COVER". PT HAD BEEN GIVEN ETOMIDATE AND VECURONIUM, AND COULD NOT BE VENTILATED. PT DESATURATED INTO 30'S, HAD 6-8 SECOND BURST OF V-TACH. WAS VENTILATED SUCCESSFULLY AFTER INTUBATION WITH VENTILATOR. NO APPARENT NEGATIVE EVENTS AFTER ADEQUATE VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIRK MEDICAL SYSTEMS DISPOSABLE RESUSCITATION BAG BTM KIRK SPECIALTY SYSTEMS ADULT CAPROFLOW K7021 7021 69027

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening