BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4170473 · Received October 3, 2014

    Report

    Report Number
    2031172-2014-00233
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO REGARDING THE EVENT AND MULTIPLE REQUESTS WERE MADE TO HAVE THE CUSTOMER RETURN THE PRODUCT INVOLVED IN THE EVENT. THE UNIT HAS NOT BEEN RETURNED AND THEREFORE, AN EVAL OF THE DEVICE INVOLVED IN THE EVENT COULD NOT BE PERFORMED. THE SAFETYNET TREND AND SOFTWARE INFO WAS MADE AVAILABLE FOR REVIEW. PER THE SYSTEM CONFIGURATION INFO THE SYSTEM WAS RUNNING IN CENTRAL MONITORING MODE. PER THE TREND DATA, THE SYSTEM WAS MONITORING AND GENERATING ALARMS ON THE SAFETYNET VIEW DURING THE PERIOD IN QUESTION AS DESIGNED. IF NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A PT DIED WHILE BEING MONITORED ON THE PT SAFETYNET SYSTEM DURING THE NIGHT. THE PT WAS ADMITTED TINT THE SYSTEM AND THE ALARMS WERE NOTED AS ACTIVE AT THE NURSING STATION AS WELL AS THE BEDSIDE. INFO WAS MADE AVAILABLE TO MASIMO ON 9/23/2014 THAT THE PT SUFFERED AN EMBOLISM THAT CAUSED ALARMS ON BOTH THE VIEW AND THE BEDSIDE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619925 RADICAL-7 HANDHELD OXIMETER DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death