BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE MODULE

    MDR report key: 5193749 · Received November 1, 2015

    Report

    Report Number
    2031172-2015-01238
    Event Type
    Malfunction
    Date Received
    November 1, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 6, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    GWQ
    PMA / PMN Number
    K051874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # WAS 2031172-2015-01239, HOWEVER THE CORRECT MDR # SHOULD BE 2031172-2015-01238.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. THE PRODUCT IS CURRENTLY BEING USED BY OTHER ANESTHESIOLOGISTS AT THE HOSPITAL AND THEY HAD NO PROBLEMS WITH THE PRODUCT. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. ACEVEDO FELT THE "BIS NUMBER" IS NOT ALIGNING OR CORRESPONDING WITH HER PATIENTS STATE DURING THE VARIOUS STAGES OF HER CASES. SHE FEELS THAT SEDLINE IS TAKING TOO LONG TO REACT AND THAT HER PATIENTS ARE MOVING WHEN THE NUMBER CLEARLY STATES THAT THEY SHOULD BE WELL WITHIN THE AMNESTIC RANGE. SHE ALSO STATED THAT THIS IS NOT PATIENT SPECIFIC, OR DEVICE SPECIFIC AND SHE JUST DOESN'T FEEL COMFORTABLE USING SEDLINE WITHOUT FURTHER EDUCATION. THE DEVICE ARE NOT BEING RETURNED BECAUSE THEY ARE IN EVERY OR AND ARE BEING USED BY OTHER ANESTHESIA STAFF WITHOUT COMPLAINT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724366 SEDLINE MODULE OXIMETER GWQ MASIMO CORPORATION 24295

    Patients

    Seq Age Sex Outcome Treatment
    1