BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 COLOR SCREEN HANDHELD

    MDR report key: 4812461 · Received May 29, 2015

    Report

    Report Number
    2031172-2015-00808
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    SERIAL # UPDATED TO (B)(4). PMA 510(K) # UPDATED TO K110028. MFG DATE : UPDATED TO 12/11/2014. THE RETURNED DEVICE WAS EVALUATED, BOTH MANUAL AND PRESET SIMULATION TESTS PASSED. THE DEVICE IS FUNCTIONING AS DESIGNED. NO PRODUCT PERFORMANCE ISSUE IDENTIFIED, BASED ON THE INVESTIGATION, THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. A REVIEW OF THE HISTORY FOR THIS DEVICE WAS PERFORMED AND IT WAS CONCLUDED THAT THE DEVICE WAS IN THE FIELD FOR OVER FOUR (4) MONTHS WITH NO PREVIOUS RETURNS FOR SERVICING OR OTHER ISSUES PRIOR TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS PROVIDING INACCURATE READINGS OF SPO2. IT WAS CONSTANTLY READING HIGH SPO2 VALUES - 99 PERCENT SPO2. THE EXPECTED SPO2 READING SHOULD BE UNDER 90 PERCENT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349346 RADICAL-7 COLOR SCREEN HANDHELD OXIMETER DQA MASIMO CORPORATION 25052

    Patients

    Seq Age Sex Outcome Treatment
    1 MASIMO DISPOSABLE SENSOR