BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT

    MDR report key: 7895518 · Received September 20, 2018

    Report

    Report Number
    2031172-2018-00474
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    August 29, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    00843997010771
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 ROOT'S LOG FILES WERE REVIEWED, WHICH REVEALED SEVERAL CORE BOARD CRITICAL FAILURES, WHICH WOULD HAVE LIKELY RESULTED IN WATCHDOG ALARMS. FURTHER ANALYSIS WAS UNABLE TO ISOLATE THE CAUSE OF THE RECORDED FAILURES AS THE UNIT WAS FOUND TO BE FULLY FUNCTIONAL. THE ERROR IS POTENTIALLY DUE TO A CORE BOARD SOFTWARE FAILURE OR A FAILURE OF THE DIGITAL SIGNAL PROCESSOR. THE EXACT CAUSE WAS NOT ABLE TO BE DETERMINED. NO PERFORMANCE ISSUES WERE IDENTIFIED WITH THE CONCOMITANT MODULE. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR ELEVEN (11) MONTHS WITH NO PREVIOUS ISSUES RELATED TO THIS REPORTED EVENT. (BRAND NAME) WAS UPDATED FROM "O3 REGIONAL OXIMETER MODULE" TO "ROOT" (COMMON DEVICE NAME) WAS UPDATED FROM "MUD" TO "MWI" (MODEL#) WAS UPDATED FROM "24667" TO "26223". (CATALOG#) WAS UPDATED FROM "9637" TO "9515". (SERIAL#) WAS UPDATED FROM "(B)(4)" TO "(B)(4)". (UDI#) WAS UPDATED FROM "(B)(4)" TO "(B)(4)". (CONCOMITANT PRODUCT AND THERAPY DATES) WAS UPDATED FROM "ROOT" TO "O3 REGIONAL OXIMETER MODULE" (PMA/510K) WAS UPDATED FROM "K160526" TO "K140188". (DEVICE MANUFACTURE DATE) WAS UPDATED FROM "12/06/2017" TO "12/18/2017".

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE O3 PARAMETER DISAPPEARS FROM THE SCREEN DURING USE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE O3 PARAMETER DISAPPEARS FROM THE SCREEN DURING USE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735273 ROOT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 26223 00843997010771

    Patients

    Seq Age Sex Outcome Treatment
    1 O3 REGIONAL OXIMETER MODULE| ROOT