BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE KIT

    MDR report key: 8045024 · Received November 6, 2018

    Report

    Report Number
    2031172-2018-00538
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 30, 2018
    Report Date
    October 14, 2018
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    00843997009096
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED SEDLINE MODULE WAS EVALUATED. VISUAL INSPECTION UPON RECEIVING REVEALED NO EXTERNAL DAMAGE OR DEFECTS. MODULE TESTED FOR 5 MINUTES CONTINUOUSLY AND NO ERROR WAS OBSERVED. NO INTERNAL DEFECTS OR DAMAGE OBSERVED. PSI COMPARISON MEASUREMENTS WERE OBTAINED USING MASIMO ROOT AND CUSTOMER EEG SENSOR FOR 10 MINUTES. THE MODULE PASSED THE PSI COMPARISON MEASUREMENTS. THE MODULE WAS DETERMINED TO BE FULLY FUNCTIONAL. INITIAL REPORTER PHONE NUMBER AND ADDRESS EXCEED THE MAXIMUM ALLOWABLE CHARACTERS. ADDRESS AND PHONE INFORMATION ARE AS FOLLOWS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HIGH PSI VALUES WHEN THERE IS RELATIVELY LOW/NO EMG/ARTF AND SEF VALUES ARE LOW AS WELL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED 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. INITIAL REPORTER PHONE NUMBER AND ADDRESS EXCEED THE MAXIMUM ALLOWABLE CHARACTERS. ADDRESS AND PHONE INFORMATION ARE AS FOLLOWS: (B)(6). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH PSI VALUES WHEN THERE IS RELATIVELY LOW/NO EMG/ARTF AND SEF VALUES ARE LOW AS WELL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880882 SEDLINE KIT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 25761 00843997009096

    Patients

    Seq Age Sex Outcome Treatment
    1