BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE

    MDR report key: 6572100 · Received May 17, 2017

    Report

    Report Number
    2031172-2017-00569
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 19, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED MODULE WAS EVALUATED. DURING EVALUATION THE MODULE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE MODULE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. (B)(6). COMMON DEVICE NAME: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS). PROCODE: MWI. MODEL #: 25761. SERIAL #: (B)(4). OCCUPATION: FOREIGN, HEALTH PROFESSIONAL, USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THERE WAS SOME CASES THAT PSI GOT HIGH ALTHOUGH THE PATIENT WAS UNDER SEDATION". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354932 SEDLINE MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 25761

    Patients

    Seq Age Sex Outcome Treatment
    1