BEUDAMED
    FDA Adverse Event Death Summary report: N

    PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT

    MDR report key: 93868 · Received May 30, 1997

    Report

    Report Number
    1217052-1997-00024
    Event Type
    Death
    Date Received
    May 30, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 30, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F10. DEVICE CODE 2203 (OTHER): NO DEVICE FAILURE. F.11 - FOLLOW-UP WITH RISK MANAGEMENT AT THE HOSPITAL REVEALS THAT A MEDWATCH REPORT WAS NOT SUBMITTED BY THE USER FACILITY. THE REPORTED REF. AS SUBMITTED ON 5/30/97 IS THE REPORT SUBMITTED BY CO. THE DEVICE MFR.

    Description of Event or Problem · 1

    PERCUTANEOUS DILATIONAL TRACHEOSTOMY WAS PERFORMED EIGHT DAYS FOLLOWING MULTIPLE BLUNT TRAUMA. DURING THE PROCEDURE, THE PT DEVELOPED HYPOXEMIA, PRESUMED LEFT PNEUMOTHORAX, AND LOSS OF AIRWAY WHICH REQUIRED REINTUBATION. THE TRACHEOSTOMY TUBE WAS SUBSEQUENTLY PLACED, BUT THE PT HAD BECOME BRADYCARDIC AND PROGRESSED TO CARDIAC ARREST. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL. PT DEMISE WAS DETERMINED ONE HOUR POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT TRACHEOSTOMY TUBE AND TUBE CUFF BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death A VENTILATOR.