BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVOS 5100C MONITOR

    MDR report key: 2220197 · Received August 15, 2011

    Report

    Report Number
    1831181-2011-00001
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    COVIDIEN - FORMERLY SOMANETICS
    Product Code
    MUD
    PMA / PMN Number
    K082327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO ON THE EVENT, NO RESPONSES WERE RECEIVED. THE SERIAL NUMBER IS UNK, THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. IT IS UNK HOW THE DEVICE WAS USED, ENVIRONMENT OF CARE SURROUNDING THE REPORT EVENT, AND WHAT VARIABLES MAY BE RELATED TO THE REPORTED PT CONDITION. THE PRODUCT LABELING INDICATES THAT INVOS RSO2 INDEX VALUES MAY NOT REPRESENT ABSOLUTE VENOUS OXYGEN SATURATION OR REFLECT OXYGENATION DISTURBANCES THAT OCCUR ELSEWHERE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT ALLEGING THAT THE DEVICE WAS PROVIDING READINGS OF 80-90 WHILE PT WAS HAVING DEEP BRAIN OXYGENATION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVOS 5100C MONITOR CEREBRAL OXIMETER SYSTEM MUD COVIDIEN - FORMERLY SOMANETICS 5100C-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability