BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN TUBING (GREEN) WITH 2 STANDARD CONNECTORS

    MDR report key: 6129318 · Received November 16, 2016

    Report

    Report Number
    6129318
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 16, 2016
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND PER HER DAUGHTER SITTING ON THE FLOOR BETWEEN THE SHOWER AND HER WHEELCHAIR. PATIENT DID NOT CALL DAUGHTER FOR ASSISTANCE. PATIENT NOTED WITH A LARGE FRONTAL SCALP HEMATOMA. PATIENT STATED SHE TRIPPED OVER OXYGEN TUBING AND LANDED ON HER HEAD. DAUGHTER HAD PLACED A BAG OF ICE ON PATIENT'S HEAD. PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL DUE TO COMPLAINTS OF NECK PAIN AND THEN TRANSPORTED VIA HELICOPTER TO A TRAUMA HOSPITAL DUE TO CT SCAN REVEALING A C1, C2 FRACTURE. SURGEON RECOMMENDED PLACEMENT OF ROD TO STABILIZE FRACTURE HOWEVER THE FAMILY OPTED FOR NON-OPERATIVE TREATMENT. ASPEN BRACE APPLIED. DURING HOSPITAL STAY HER PLEURAL EFFUSION INCREASED AND DAUGHTER EXPRESSED INPATIENT COMFORT CARE ONLY FOR PATIENT. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758121 OXYGEN TUBING (GREEN) WITH 2 STANDARD CONNECTORS OXYGEN SUPPLY TUBING - 25 FEET BYX SALTER LABS 2025G-25

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| O OVERBED TABLE| OXYGEN CONCENTRATOR| OXYGEN PORTABLE SYSTEM (E-CYLINDER)| STANDARD 18" WHEELCHAIR