BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE KIT

    MDR report key: 6231971 · Received January 8, 2017

    Report

    Report Number
    2031172-2017-00032
    Event Type
    Malfunction
    Date Received
    January 8, 2017
    Date of Event
    December 15, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED MODULE WAS EVALUATED. DURING TESTING THE MODULE COULD NOT SUCCESSFULLY ESTABLISH COMMUNICATION WITH THE ROOT AND THE MONITOR DISPLAYED "GEL BRIDGING DETECTED." THE MODULE WAS CONNECTED TO A COMPUTER IN ORDER TO TAKE MEASUREMENTS AND A "GEL BRIDGING" MESSAGE WAS SHOWN. THE MODULE IS SEALED AND CANNOT BE OPENED FOR INTERNAL INSPECTION, NO DEFECTS WERE OBSERVED VIA X-RAY INSPECTION. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER TWO (2) YEARS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT., CORRECTED : COMMON DEVICE NAME CORRECTED FROM ELECTROENCEPHALOGRAPH TO MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) PRODUCT CODE CORRECTED FROM GWQ TO MWI. 510K CORRECTED FROM K140188 TO K151644.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE STOPPED MEASURING, AND NO READING COULD BE OBTAINED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15209 SEDLINE KIT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 24295

    Patients

    Seq Age Sex Outcome Treatment
    1