BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 3999411 · Received August 1, 2014

    Report

    Report Number
    2031172-2014-00123
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. DURING AN INTERNAL INSPECTION OF THE DEVICE, THE UNIT WAS FOUND TO HAVE A FAILED POWER SUPPLY, THEREFORE THE DEVICE WAS NOT ABLE TO ENGAGE IN MONITORING ACTIVITIES. A REPLACEMENT DEVICE WAS PROVIDED TO THE REPORTER. INFORMATION WAS MADE AVAILABLE TO MASIMO THAT THE UNIT WAS NOT BEING USED TO MONITOR THE PATIENT AT THE TIME OF THE PATIENT DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD ONLY ONE BAR OF BATTERY LIFE LEFT; A LOW BATTERY ALARM WAS CONFIRMED TO HAVE OCCURRED. ROB INSTRUCTED THE END USER TO CHARGE THE UNIT. HE STATED THAT THE END USER DISCONNECTED THE RAD-8 FROM THE PATIENT AND LEFT THE UNIT CHARGING OVERNIGHT. THE NEXT MORNING WHEN THE END USER TRIED TO POWER ON THE RAD-8, THE UNIT WOULD NOT POWER ON. A MASIMO CLINICAL SPECIALIST CONTACTED MASIMO TECHNICAL SUPPORT TO CANCEL THE RETURN AS THE END USER INDICATED THAT THEY WILL NO LONGER SEND IN THE DEFECTIVE UNIT AS THE PATIENT HAD PASSED AWAY ABOUT AN HOUR AGO. ROB STATED THAT THE RAD-8 DEVICE WAS NOT CONNECTED TO THE PATIENT WHEN THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449476 RAD-8 DQA MASIMO CORPORATION 9190

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death