BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU SPUR II ADULT RESUSCITATOR

    MDR report key: 2949469 · Received January 29, 2013

    Report

    Report Number
    MW5028872
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 29, 2013
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AMBU RESUSCITATOR MANUFACTURED BY AMBU, INC. REF # (B)(4) LOT# 1420637 FAILED TO INFLATE AFTER ONLY ONE DEFLATION. COMPLAINT FILED WITH AMBU, INC. THEY WILL PICK UP ITEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38589 AMBU SPUR II ADULT RESUSCITATOR BTM 521611000 1420637

    Patients

    Seq Age Sex Outcome Treatment
    1