BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8772515 · Received July 9, 2019

    Report

    Report Number
    3010150334-2019-00008
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    February 13, 2018
    Report Date
    July 9, 2019
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    UDI-DI
    B213301112140
    PMA / PMN Number
    K171423
    Removal / Correction Number
    3010150334-50819-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ARRIVAL TO THE OPERATION ROOM, ANESTHESIA REMOVED PULSE OXIMETER CLIP FROM RIGHT SIDE OF THE NOSE. PRESSURE ULCER NOTED UNDER THE PULSE OXIMETER CLIP WAS A DARK REDDENED AREA SURROUNDED BY BLACK SKIN. ANESTHESIA CLEANED SKIN UNDER THE CLIP, AND APPLIED A NEW PULSE OXIMETER TO THE FINGER. PROGRESS NOTE READS: PRESSURE ULCER NOTED UNDER PULSE OXIMETER ON RIGHT SIDE OF NOSE. SKIN APPEARS BLACK WITH A REDDENED AREA. OTHER NOTES: PATIENT VITAL SIGNS: BP NORMAL TENSIVE (DIASTOLIC 120-150MMHG); RR TACHYCARDIC; TEMP 99.1 - 100.6 F. PATIENT ON VENTILATOR; BEDREST/BEDBOUND ON SKIN PRECAUTIONS (BRADEN SCORE FOR PRESSURE ULCERS SCORED PATIENT HIGH RISK.) THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567315 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214 TR101737 B213301112140

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention