BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE KIT

    MDR report key: 7097367 · Received December 7, 2017

    Report

    Report Number
    2031172-2017-01079
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 14, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    00843997009096
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. 510K# CORRECTED FROM K051874 TO K151644.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: THE DEVICE HAS BEEN RETURNED TO THE LOCAL FACILITY BUT HAS NOT YET BEEN RECEIVED AT THE MAIN OFFICE FOR EVALUATION. ONCE THE DEVICE HAS BEEN RETURNED AND INVESTIGATED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT DETECTION PROBLEMS WHEN THE SENSOR IS BEING USED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875832 SEDLINE KIT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 25761 00843997009096

    Patients

    Seq Age Sex Outcome Treatment
    1