BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DISPOSABLE ADULT RESUSCITATION BAG

    MDR report key: 3131264 · Received May 23, 2013

    Report

    Report Number
    1044475-2013-00079
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 10, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING TRAINING EXERCISE THE REBREATHER BAGS WERE FOUND RIPPED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230406 HUDSON DISPOSABLE ADULT RESUSCITATION BAG DISPOSABLE ADULT MANUAL RESUSCITATOR BTM TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1