BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU SPUR

    MDR report key: 416454 · Received September 12, 2002

    Report

    Report Number
    416454
    Event Type
    Injury
    Date Received
    September 12, 2002
    Date of Event
    August 14, 2002
    Report Date
    September 11, 2002
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    O2 LINE DISCONNECTS FROM BAG. THIS HAS OCCURRED ON AT LEAST 2 ARREST SITUATIONS. INVESTIGATION HAS DETERMINED THAT THE SUPPLY LINE EASILY DISCONNECTS ON ROUGHLY HALF OF IN HOUSE STOCK AND INVOLVES ALL LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR INFANT TUBE RESERVOIR BTM AMBU INC. * A11

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention