BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8 PULSE OXIMETER

    MDR report key: 3578981 · Received January 8, 2014

    Report

    Report Number
    2031172-2014-00004
    Event Type
    Death
    Date Received
    January 8, 2014
    Date of Event
    December 3, 2013
    Report Date
    December 9, 2013
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT A DEATH WAS REPORTED TO HAVE OCCURRED, HOWEVER THE DEVICE WAS NOT BEING USED ON THE PT AT THE TIME. THE CUSTOMER INDICATED THAT THE DEVICE WOULD BE RETURNED. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVAL OR NEW INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD-8 UNIT WAS NOT WORKING AS IT WAS UNABLE TO OBTAIN A READING USING DIFFERENT SENSORS. THE UNIT WAS THEN TAKEN OUT OF SERVICE BY THE CAREGIVER. A DEATH WAS REPORTED TO HAVE OCCURRED WHILE THE UNIT WAS NOT ON THE PT. ALTHOUGH IT WAS REPORTED BY THE CAREGIVER THAT THE RAD-8 UNIT WAS NOT WORKING, THE MOTHER OF THE PT INDICATED THAT "THERE WAS NOTHING WRONG WITH THE UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14465 RAD-8 PULSE OXIMETER DQA MASIMO CORPORATION RAD-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death