BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUBE ENDOTRACHEAL PRESTYLE 7.0

    MDR report key: 7626276 · Received June 18, 2018

    Report

    Report Number
    7626276
    Event Type
    Death
    Date Received
    June 18, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 15, 2018
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY FOR HIP FRACTURE. DEVELOPED DECREASED OXYGEN SATURATION IN PACU WITH INCREASED SWELLING OF NECK AND CREPITUS. X-RAY REVEALED EXTENSIVE SUBCUTANEOUS GAS/PNEUMOMEDIASTINUM. TRANSFERRED TO TERTIARY CARE INTUBATED ON VENTILATOR FOR CARDIOTHORACIC EVALUATION. REMAINED IN ICU. PT BECAME UNRESPONSIVE. CT OF HEAD OBTAINED REVEALING A SUBACUTE RIGHT ACA INFARCT AS WELL AS A CHRONIC RIGHT MCA INFARCT. FAMILY MADE PT COMFORT MEASURES ONLY AND PT EXTUBATED AND EXPIRED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454263 TUBE ENDOTRACHEAL PRESTYLE 7.0 ENDOTUBE BTR SALTER LABS 11726 1708ST1400L

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death| H| R