BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS OXYGEN TUBING

    MDR report key: 7355976 · Received March 20, 2018

    Report

    Report Number
    3000219639-2018-00003
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    June 26, 2017
    Report Date
    March 21, 2018
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT FOUND DURING REVIEW OF MAUDE DATABASE. PER INITIAL REPORT, NO MALFUNCTION. LOT NUMBER NOT PROVIDED; INITIAL REPORTER INFORMATION NOT PROVIDED, FURTHER INVESTIGATION IS NOT POSSIBLE. NOT PREVIOUSLY REPORTED TO SALTER LABS. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 0

    COMPANION REPORT TO (B)(4). THE PATIENT WAS BEING ASSISTED TO THE BATHROOM BY AN AIDE WHO TRIPPED OVER THE TUBING, CAUSING THE PATIENT TO ALSO FALL. INJURY REPORTED (HIP FRACTURE). PATIENT WAS TREATED AT HOSPITAL FOR PAIN ONLY PER FAMILY REQUEST, AND SUBSEQUENTLY DIED. NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195111 SALTER LABS OXYGEN TUBING OXYGEN TUBING BYX SALTER LABS 2025G N/A

    Patients

    Seq Age Sex Outcome Treatment
    0 Death