BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7

    MDR report key: 5164405 · Received October 21, 2015

    Report

    Report Number
    2031172-2015-01189
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 25, 2015
    Manufacturer
    MASIMO
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETUNED DEVICE WAS EVALUATED. DURING INVESTIGATION IT WAS FOUND THAT POWERING ON FOLLOWING ABRUPT POWER OFF THE "ERROR IN DATA STORAGE" MESSAGE IS PRESENT. POWERING ON FOLLOWING STANDARD SHUTDOWN SEQUENCE THERE ARE NO ERRORS PRESENT. LOG FILE INDICATES 12 TIMES THE RADICAL-7 WAS ABRUPTLY POWERED OFF. BY DESIGN THE RADICAL-7 MAY DISPLAY THE "ERROR IN DATA STORAGE" MESSAGE WHEN POWERING ON AFTER AN ABRUPT SHUTDOWN. THIS ERROR OCCURS WHEN THE RADICAL-7 DOES NOT GET TO RUN THROUGH ITS STANDARD SHUTDOWN PROTOCOL; THE ERROR OCCURS WHEN THE POWER IS INTERRUPTED WHILE THE DEVICE IS WRITING INFORMATION TO THE DEVICE MEMORY. CUSTOMER COMPLAINT REGARDING SPO2 FLUCTUATION NOT CONFIRMED. COMPLAINT REGARDING "ERROR IN DATA STORAGE" CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPO2 VALUE SHOWED DRASTICALLY FLUCTUATION 85-95% RANGE. SENSOR PLACEMENT WAS AT THE TOE. THE SITUATION WAS NOT CHANGED AFTER REPLACE THE CABLE AND SENSOR. THE SITUATION WAS NOT CHANGED AFTER SENSOR PLACEMENT AREA (TOE) WAS SWITCHED. THEN, THE SPO2 MEASUREMENT WAS SWITCHED TO NIHON KOHDEN MONITOR AND SPO2 VALUE 100% CAME UP. BLOOD GAS ANALYZER ALSO SHOWED 100%. PI: 1-3 THERE WERE NO LIGHT EMISSION OR/AND ELECTRICAL INSTRUMENTS AROUND SENSOR PLACEMENT AREA. TECH SUPPORT-MJC CONFIRMED "ERROR IN DATA STORAGE" MESSAGE CAME UP, OCCURS IN BOTH CONDITION OF THE AC DRIVE AND BATTERY DRIVE. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695104 RADICAL-7 OXIMETER DQA MASIMO 23789

    Patients

    Seq Age Sex Outcome Treatment
    1