BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    SPECTROS T-STAT

    MDR report key: 13522846 · Received February 14, 2022

    Report

    Report Number
    13522846
    Event Type
    No answer provided
    Date Received
    February 14, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 1, 2022
    Manufacturer
    SPECTROS CORPORATION
    Product Code
    MUD
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    POSTANESTHESIA CARE UNIT (PACU) REGISTERED NURSE NOTIFIED SURGEON OF LOW OXYGEN (O2) SATURATION READINGS FROM THE SPECTROS T-STAT® 2.0 MICROVASCULAR TISSUE OXIMETER TO THE LEFT BREAST. SURGEON ARRIVED TO EXAMINE PATIENT AND PATIENT WAS BROUGHT BACK TO SURGERY FOR A SURGICAL EXPLORATION OF THE LEFT BREAST. ANOTHER T-STAT® MACHINE WAS LOCATED AND USED FOR THE LEFT BREAST AFTER SURGERY WITH ACCEPTABLE O2 SATURATION READINGS. SURGEON VERIFIED VIABLE LEFT FLAP WITH INTACT ANASTOMOSIS AND NO VESSEL ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74018 SPECTROS T-STAT OXIMETER, TISSUE SATURATION MUD SPECTROS CORPORATION T-STAT 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA Unknown