BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1053118 · Received May 5, 2008

    Report

    Report Number
    1053118
    Event Type
    Malfunction
    Date Received
    May 5, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 5, 2008
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED LARYNGOSPASM IN THE OR, WHICH WAS CONTROLLED WITH MEDICATION. SHE WAS TAKEN TO THE RECOVERY ROOM, WHERE SHE AGAIN WENT INTO LARYNGOSPASM. THE CRNA TRIED TO OPEN THE PATIENT'S AIRWAY, BUT SHE WAS OBSTRUCTING. THE TEAM STARTED TO BAG THE PATIENT WITH A PEDIATRIC-SIZED RESUSCITATION BAG. THERE WAS NO CHEST RISE. THE BAG WAS REPLACED WITH ANOTHER PEDIATRIC-SIZED RESUSCITATION BAG. THAT ONE ALSO RESULTED IN NO CHEST RISE. THE TEAM SWITCHED TO AN ADULT SIZED RESUSCITATION BAG MADE BY A DIFFERENT MANUFACTURER. THE PATIENT WAS INTUBATED, AND THEY WERE ABLE TO BRING HER SATURATION RATE BACK TO NORMAL. THE WHOLE EVENT LASTED APPROXIMATELY 90 SECONDS, AND THE PATIENT SUFFERED NO SEQUELA. AFTER THE EVENT, THE TEAM EXAMINED THE TWO BAGS, AND ONE HAD A 0.5 CM TEAR IN IT. THE OTHER HAD A HOLE NEAR THE CONNECTION TO THE CIRCUIT. ALL THE BAGS BY THIS MANUFACTURER WERE INSPECTED, AND THE RUBBER APPEARS TO BE DETERIORATING. THE RUBBER IS THIN, AND EXPOSURE TO THE HEAT OF THE LIGHTS ON THE HEADRAIL WHERE THE RESUSCITATION BAGS ARE KEPT MAY BE A CONTRIBUTING FACTOR TO THEIR DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BAG, RESUSCITATION BTM VENTLAB CORPORATION VN4100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR OTHER| OTHER