BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO SEDLINE MODULE

    MDR report key: 16885349 · Received May 8, 2023

    Report

    Report Number
    9610816-2023-00213
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    January 9, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    OLW
    UDI-DI
    00884838051515
    PMA / PMN Number
    K003038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTING INSTITUTION NAME: (B)(6) HOSPITAL. REPORTING ADDRESS STATE: (B)(6).

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) ATTEMPTED TO REACH OUT TO THE CUSTOMER AND RECEIVED NO RESPONSE. IT IS UNKNOWN IF THE DEVICE WAS EVALUATED OR WHAT CAUSED THE ISSUE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM IS UNKNOWN. THE REPORTED PROBLEM WAS NOT CONFIRMED. IT IS UNKNOWN IF THE DEVICE IS BACK IN SERVICE DUE TO INSUFFICIENT INFORMATION. THE CUSTOMER DID NOT CALL BACK OR EMAIL BACK FOR FURTHER SUPPORT. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. H3 OTHER TEXT : NO RESPONSE FROM CUSTOMER.

    Description of Event or Problem · 0

    THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066628 MASIMO SEDLINE MODULE MASIMO SEDLINE MODULE OLW PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867186 00884838051515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown