BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8 HORIZONTAL

    MDR report key: 5193751 · Received November 1, 2015

    Report

    Report Number
    2031172-2015-01237
    Event Type
    Death
    Date Received
    November 1, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 6, 2015
    Manufacturer
    MASIMO
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    REQUEST BY CUSTOMER TO HELP WITH DOWNLOADING DATA FROM RAD 8 SERIAL NUMBER (B)(4). THE CUSTOMER HAD PROBLEMS TRYING TO DOWNLOAD DATA USING (B)(4) DOWNLOAD AND REQUESTED HELP TO DO THIS AS AN URGENT MATTER YESTERDAY (B)(6) 2015. THE REASON FOR THE URGENT DOWNLOAD WAS THAT THERE HAD BEEN AN INCIDENT IN (B)(6) AND THAT THE RAD 8 WAS A PIECE OF EVIDENCE IN A POLICE CASE AND THEY REQUIRED THE DATA FROM THE RAD 8. MASIMO REP ATTEMPTED (B)(4)-DOWNLOAD AFTER OVER 2 HOURS AND 92000 PACKETS OF DATA HAD BEEN DOWNLOADED THE PROGRAMME CRASHED. ANOTHER DOWNLOAD WAS THEN TRIED USING (B)(4) LATEST VERSION THIS ALSO WAS UNSUCCESSFUL. THE MASIMO REP INFORMED (B)(4) HE WAS UNABLE TO HELP ANY MORE AND SUGGESTED THAT THE MONITOR BE RETURNED TO THE US TO SEE IF THE DATA CAN BE DOWNLOADED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A PATIENT DEATH. THE DATE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724436 RAD-8 HORIZONTAL OXIMETER DQA MASIMO 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death