BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA TRACHEOFLEX TRACHEOSTOMY SET

    MDR report key: 62663 · Received January 7, 1997

    Report

    Report Number
    48207-1997-00003
    Event Type
    Injury
    Date Received
    January 7, 1997
    Date of Event
    December 16, 1996
    Report Date
    January 7, 1997
    Manufacturer
    WILLY RUSCH AG
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENT ALARM WENT OFF NSQ V'D PT AND FOUND THAT TRACH TUBE WAS PARTIALLY DISLODGED, VENT CIRCUIT/TUBES APPEARED TO BE TAUT WHILE PT WAS TURNED ON HER SIDE. NSQ STATED "TUBE APPEARED TOO SHORT" LOCK RING HAD MOVED FROM PROPER MARKED LEVEL TRACH TUBE IMMEDIATELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA TRACHEOFLEX TRACHEOSTOMY SET TRACHEOSTOMY TUBE BTO WILLY RUSCH AG NA 96411

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention