BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU SPUR II

    MDR report key: 779461 · Received November 9, 2006

    Report

    Report Number
    MW1040903
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    September 19, 2006
    Report Date
    November 3, 2006
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    AMBU RESUSCITATION BAG (SPUR II) WITH OPEN TUBE RESERVOIR. RESERVOIR EASILY PULLS OFF INLET PORT. EXPOSES OXYGEN SUPPLY LINE, WHICH IS NOT ATTACHED TO A NIPPLE. SUPPLY LINE LAYS IN A "U" - SHAPE CHANNEL AND BECAME DISLODGED. RESULT WITH NO OXYGEN FLOW TO BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR II ADULT RESUSCITATION BAG BTM AMBU INC. SPUR II UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention