BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE

    MDR report key: 103114 · Received July 1, 1997

    Report

    Report Number
    103114
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 4, 1997
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT TRANSFERRED FROM ANOTHER FACILITY WITH TRACHEOSTOMY TUBE ALREADY IN PLACE. PT PLACED ON BARIKARE ELECTRIC BED WITH A PRESSURE RELIEF MATTRESS OVERLAY. THE BED WAS ADJUSTED SO THAT PT WAS SITTING UPRIGHT. PT SUBSEQUENTLY SLID DOWN THE LENGTH OF THE BE TO THE FLOOR, RESULTING IN THE VELTILATOR CIRCUIT PULLING ON THE TRACHEOSTOMY TUBE. EIGHT HOURS LATER, THERE WERE PROBLEMS WITH THE TUBE SLIDING UP AND DOWN. 36 HOURS LATER, THE PT'S AIRWAY OCCLUDED AND HE ARRESTED (ASYSTOLE). HE WAS SUCCESSFULLY RESCUSITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE HYPERFLEX TRACHEOSTOMY TUBE ADJUSTABLE LENGTH TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R FIRST STEP HEAVY DUTY PUMP MOD. 40525C| FIRST STEP HEAVY DUTY MATTRESS| BARIKARE BED MOD. 73186