BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBE

    MDR report key: 7674163 · Received July 10, 2018

    Report

    Report Number
    3000219639-2018-00005
    Event Type
    Death
    Date Received
    July 10, 2018
    Date of Event
    June 8, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    UDI-DI
    00607411958014
    PMA / PMN Number
    K042683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THIS INFORMATION, THERE WAS A DEVICE MALFUNCTION. PHOTOS PROVIDED SHOW CUFF FAILURE. DEATH OCCURRED BUT RELATIONSHIP TO DEVICE MALFUNCTION NOT ESTABLISHED. CAUSE MOST LIKELY DUE TO MULTIPLE DISEASE STATES. THIS IS A COMPANION REPORT TO FACILITY REPORT (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGERY AND SUBSEQUENTLY DEVELOPED DECREASED OXYGEN SATURATION. X-RAY REVEALED PNEUMOMEDIASTINUM. PATIENT WAS INTUBATED AND PLACED ON VENTILATOR. PATIENT WAS DETERMINED TO HAVE A SUBACUTE RIGHT ACA INFARCT AND CHRONIC RIGHT MCA INFARCT. PATIENT EXPIRED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516595 SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR SALTER LABS H-PFST-70-10 1708ST14001K 00607411958014

    Patients

    Seq Age Sex Outcome Treatment
    1 Death