BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SEDLINE SENSOR

    MDR report key: 7676297 · Received July 10, 2018

    Report

    Report Number
    2031172-2018-00381
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 17, 2018
    Report Date
    June 17, 2018
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    10843997011775
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSORS WAS EVALUATED. DURING EVALUATION, BOTH THE SENSORS WERE FOUND TO BE DEFECTIVE. THE RETURNED SENSOR FAILED CONTINUITY TESTING DUE TO MULTIPLE OPEN CIRCUITS. THE SENSORS WERE RETURNED USED AND COULD NOT BE TESTED FURTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED: "THE SPECTRAL EDGE READ COMPLETELY DIFFERENTLY ON BOTH SIDES OF THE BRAIN. THERE WAS NOTHING TO SUGGEST THESE READINGS WERE ACCURATE IN TERMS OF BRAIN FUNCTION. THE CASE WAS COSMETIC SURGERY AND ONE PART OF THE SURGERY, AN EYE LIFT. THERE WAS A LOT OF INTERFERENCE WITH THE DIATHERMY AND THE SEF WAS, AS MENTIONED TOTALLY DIFFERENT. THE PSI WAS OFTEN AFFECTED EVEN WHEN THERE WAS NO MOVEMENT OR INTERFERENCE THE SEF APPEARED COMPLETELY ASYMMETRICAL AND NOT WHAT YOU WOULD HAVE EXPECTED WITH THIS PATIENT". NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515020 RD SEDLINE SENSOR MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 4248-9 E17EMQ 10843997011775

    Patients

    Seq Age Sex Outcome Treatment
    1