BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 6159809 · Received December 9, 2016

    Report

    Report Number
    2031172-2016-01402
    Event Type
    Death
    Date Received
    December 9, 2016
    Date of Event
    November 12, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED DEVICE WAS EVALUATED. THE RAD-8 WAS UNABLE TO POWER ON, AND THE AC LED DID NOT ILLUMINATE WHEN AC POWER WAS CONNECTED. INTERNAL INSPECTION INDICATED THE UI RIBBON CABLE WAS DISCONNECTED FROM THE SYSTEM BOARD (J14). IN THIS CONDITION, THE DEVICE WOULD NOT HAVE BEEN ABLE TO ENGAGE IN PATIENT MONITORING. THE CABLE WAS RECONNECTED, AND TESTING RESUMED. THE DEVICE WAS ABLE TO POWER ON WITH AC AND DC POWER, AND REMAINS POWERED ON WHEN SWITCHING BETWEEN POWER SOURCES. THE DEVICE WAS ABLE TO OBTAIN READINGS NORMALLY USING THE RETURNED CABLE; ALARM ALERT CONDITIONS, SUCH AS: NO CABLE, SENSOR OFF AND ALARM LIMITS BREACH, WITH AUDIBLE AND VISUAL STATUS INDICATORS, WERE FUNCTIONING. NO ADDITIONAL ISSUES WERE DETECTED. REVIEW OF TREND DATA SHOWS DEVICE WAS LAST USED TO ACQUIRE MEASUREMENTS ON (B)(6) 2016. THE DEVICE WAS ON FOR APPROXIMATELY 3 MINUTES ON (B)(6) 2016, BUT NO SENSOR WAS CONNECTED. THE DEVICE WAS POWERED ON FOR A FEW SECONDS MULTIPLE TIMES ON (B)(6) 2016, HOWEVER NO MEASUREMENTS WERE TAKEN AND NO SENSOR WAS CONNECTED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER ELEVEN (11) MONTHS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT., CORRECTED DATA:

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT'S FAMILY CONTACTED THE CUSTOMER TO TELL THEM THEIR RAD-8 WAS NOT WORKING AND TO TELL THEM THE PATIENT EXPIRED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809289 RAD-8 OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death LNCS NEORED LNC-04