BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 6370212 · Received March 1, 2017

    Report

    Report Number
    2031172-2017-00281
    Event Type
    Death
    Date Received
    March 1, 2017
    Date of Event
    February 7, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RAD 8 DID NOT ALARM DURING A PATIENT DESATURATION EVENT. THE PATIENT EXPIRED. BIOMED WAS CALLED AND HAS EVALUATED THE DEVICE. BIOMED STATES THAT THEY CAN FIND NOTHING WRONG WITH THE DEVICE AND HAVE CREATED ALARM CONDITIONS WHICH CAUSED THE RAD 8 TO ALARM CORRECTLY, BOTH VISUALLY AND AUDIBLY. BIOMED REQUESTED ASSISTANCE WITH DOWNLOADING TREND DATA FROM THE RAD 8. ADVISED CUSTOMER TO TURN THE RAD 8 OFF AND SEND THE MONITOR, PATIENT CABLE AND SENSOR TO MASIMO FOR DETAILED FAILURE ANALYSIS. CUSTOMER STATES THAT NO SETTINGS WERE ALTERED OTHER THAN THEY TURNED ON THE PULSE TONE TO CHECK AUDIO FUNCTION. CUSTOMER REQUESTS ALL TREND DOWNLOAD DATA AND ALARM SILENCE DURATION SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151817 RAD-8 OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LNCS NEO ADHESIVE SENSOR, RED LNC-10 PATIENT CABLE