BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8769486 · Received July 8, 2019

    Report

    Report Number
    3010150334-2019-00004
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    November 21, 2017
    Report Date
    July 8, 2019
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    PMA / PMN Number
    K171423
    Removal / Correction Number
    3010150334-50819-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIOTHORACIC PATIENT, MULTIPLE DRIPS IN THE OPERATION ROOM FOR 10 HOURS. THE NURSES ARE DOING EVERY 2 HOUR POSITION CHANGES WITH THEM. ANESTHESIA IS USING THEM AND NOT DOING ANY REPOSITIONING OF THEM WHILE IN THE OPERATING ROOM. IN THE PAST MONTH THERE HAVE BEEN 3 PATIENTS WITH 4 DEEP TISSUE INJURIES. ONE PATIENT HAD ONE ON EACH NOSTRIL. ALL OF THE PATIENTS HAD LONG OPERATING ROOM TIMES, LVAD'S OR ECMO'S. ALL ON MULTIPLE PRESSERS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WIL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561921 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention