BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE

    MDR report key: 6116821 · Received November 21, 2016

    Report

    Report Number
    2031172-2016-01311
    Event Type
    Malfunction
    Date Received
    November 21, 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

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED MODULE WAS EVALUATED. VISUAL INSPECTION SHOWED THAT THE BEND RELIEF SLEEVE HAS COME LOOSE FROM MODULE. NO PRODUCT PERFORMANCE ISSUES RELATED TO THE REPORTED EVENT WERE IDENTIFIED, BASED ON RESULTS OF THE INVESTIGATION, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769295 SEDLINE OXIMETER GWQ MASIMO - 40 PARKER 24295

    Patients

    Seq Age Sex Outcome Treatment
    1