BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE

    MDR report key: 6111079 · Received November 17, 2016

    Report

    Report Number
    2031172-2016-01288
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 28, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    GWQ
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): 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. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED MODULE WAS EVALUATED. DURING EVALUATION THE MODULE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE MODULE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MEASUREMENT FAILURES, BROKEN PROTECTOR AND INTERMITTENT FAILURE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761534 SEDLINE OXIMETER GWQ MASIMO - 40 PARKER 24295

    Patients

    Seq Age Sex Outcome Treatment
    1