BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DISPOSABLE ADULT RESUSCITATION BAG

    MDR report key: 3131263 · Received May 23, 2013

    Report

    Report Number
    1044475-2013-00080
    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

    Additional Manufacturer Narrative · 1

    THE VENDOR DID A PRODUCT VALIDATION INDICATING THAT THE AIR WILL BE DEFLATED LITTLE BY LITTLE DURING NORMAL STORAGE, BUT THE AIR IS STILL ENOUGH AND DOES NOT AFFECT THE FUNCTION BEFORE THE THREE YR EXP DATE. THE VENDOR INDICATES THAT, PER THEIR EXPERIENCE, THE AMOUNT OF AIR DEFLATION DEPENDS ON THE TIME OF STORAGE, ESPECIALLY WHEN IT IS STORED OVER THE EXP DATE FOR ONE OR TWO YRS LATER. PER THE VENDOR, ALTHOUGH THE SAMPLE IS NOT AVAILABLE, THE PRODUCT MAY HAVE BEEN STORED OVER THE EXP DATE ACCORDING TO THEIR VALIDATION AND PAST COMPLAINT RECORD.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING TRAINING, THE AIR CUSHION MASK WAS FOUND UNDER INFLATED. NO PT INJURY/INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228740 HUDSON DISPOSABLE ADULT RESUSCITATION BAG DISPOSABLE ADULT MANUAL RESUSCITATOR BTM TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1