BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4280063 · Received November 18, 2014

    Report

    Report Number
    2031172-2014-00445
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 19, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFO WERE MADE. THE UNIT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE DEVICE IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RADICAL-7 BATTERY WAS RETURNED AND EVALUATED. DURING EVALUATION, THE BATTERY PASSED ALL VISUAL AND FUNCTIONAL TESTING AND WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. BRAND NAME WAS UPDATED TO "RADICAL-7 HANDHELD". MODEL NUMBER WAS UPDATED TO "23789" AND CATALOG NUMBER WAS UPDATED TO "9500". PMA/510(K) NUMBER WAS UPDATED TO "K140188".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RADICAL-7'S BATTERY HAD A VERY SHORT LIFE. THE BATTERY RAN OUT IMMEDIATELY EVEN THOUGH THE BATTERY INDICATOR SHOWED IT WAS FULL. NO KNOWN PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745204 RADICAL-7 HANDHELD OXIMETER DQA MASIMO CORPORATION 23789

    Patients

    Seq Age Sex Outcome Treatment
    1