BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 5409067 · Received February 3, 2016

    Report

    Report Number
    2031172-2016-00105
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    December 29, 2015
    Report Date
    January 11, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS IN RESPONSE TO AN FDA REQUEST AND IS BEING SUBMITTED TO UPDATE G8 MANUFACTURING REPORT NUMBER FOR REPORT NUMBER 2031172-2016-00078. G8 MANUFACTURING REPORT NUMBER WAS 2031172-2016-00078; IS 2031172-2016-00105.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA (G9) FOR FOLLOW-UP #: 001: UPDATED MANUFACTURER REPORT NUMBER FROM "2031172-2016-00078".

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR EIGHT (8) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RAD-8 UNIT WILL NOT RUN ON BATTERY. WHEN AC POWER IS DISCONNECTED THE UNIT SHUTS OFF. THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD-8 UNIT WILL NOT RUN ON BATTERY. WHEN AC POWER IS DISCONNECTED THE UNIT SHUTS OFF. THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66281 RAD-8 OXIMETER DQA MASIMO CORPORATION 22044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown