BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERINFLATION BAG SYSTEM

    MDR report key: 3101338 · Received May 3, 2013

    Report

    Report Number
    MW5030087
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    VITAL SIGNS- A GE HEALTHCARE COMPANY
    Product Code
    NHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VITAL SIGNS - GE- HYPERINFLATION BAG SYSTEM- 1663X3LP, LOT 6199E. UNABLE TO PRESSURIZE BAG ABOVE 5CM H2O AND THUS UNABLE TO VENTILATE PATIENTS WITH POSITIVE PRESSURE. SINCE THIS IS THE INTENDED USE OF THE DEVICE, ITS FAILURE REPRESENTS A LIFE-SAFETY HAZARD. THIS HAS BEEN FOUND TO BE A PROBLEM ON ALL INSTANCES OF THIS PRODUCT. DATE OF USE: (B)(6) 2013. REASON FOR USE: ELECTROCONVULSIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194735 HYPERINFLATION BAG SYSTEM HYPERINFLATION BAG SYSTEM NHK VITAL SIGNS- A GE HEALTHCARE COMPANY 6199E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention