BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 6194219 · Received December 21, 2016

    Report

    Report Number
    2031172-2016-01448
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 27, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE IS READING SOMETIMES HIGH, AND SOMETIMES LOW. BOTH CABLE AND SENSOR HAVE BEEN CHANGED. NO PATIENT INCIDENT REPORTED, AND WILL ENGAGE IN MONITORING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "I DOUBT ANYTHING IS WRONG WITH THE DEVICE AND WE HAVE NO REASON TO BELIEVE IT IS NOT 100% OPERATIONAL AND ACCURATE. HOWEVER, IT WAS IN THE SAME ROOM AS ONE OF OUR KIDS THAT DIED EARLIER THIS WEEK. THE CHILD WAS NOT ON THE MONITOR AT THE TIME FROM WHAT I HAVE TOLD. THERE WAS NO QUESTION ABOUT THE MONITOR OR THAT IT MIGHT HAVE ANY PROBLEM. THE CONNECTION CABLE WAS SENT WITH THE UNIT. I TURNED IT ON HERE AND EVERYTHING LOOKS NORMAL. IT SHOWS IF THE SENSOR IS DISCONNECTED FROM THE CABLE, THE SENSOR DROPS OFF THE PATIENT, CABLE NOT CONNECTED TO THE OXIMETER, CHARGES WHEN THE PLUG IS IN AND GOES TO BATTERY WHEN IT IS NOT. THE START-UP DISPLAY IS PERFECTLY NORMAL TOO. THERE IS NO PHYSICAL DAMAGE TO THE UNIT EITHER. WE DID NOT CHANGE ANY SETTINGS HERE NOR DOWNLOAD THE MONITOR WHICH WOULD SHOW IF IT WAS BEING USED AT THE TIME. TIME OF DEATH SOMEWHERE BETWEEN 6:00 TO 7:00 AM THIS PAST (B)(6) 2016.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844110 RAD-8 OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death