BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 5409580 · Received February 4, 2016

    Report

    Report Number
    2031172-2016-00119
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 11, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053269
    Removal / Correction Number
    Z-1187-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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. NO UN-COMMANDED OR UNEXPECTED SHUT DOWN OF SYSTEM OBSERVED DURING TEST AND EVALUATION. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. UNABLE TO CONFIRM COMPLAINT. PT IDENTIFIER: (B)(6). "IT WAS REPORTED THAT THE RAD-8 UNIT WILL JUST TURN OFF EVEN WHEN PLUGGED IN OR FULLY CHARGED. THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT." BRAND NAME TO RAD-8. MODEL # TO 22042, CATALOG # TO 9190, SERIAL # TO (B)(4). DEVICE AVAILABLE FOR EVALUATION? "YES", RETURNED ON 01/26/2016. INITIAL REPORTER: (B)(6). REPORTING SOURCE CHANGED TO COMPANY REPRESENTATIVE AND DISTRIBUTOR PMA 510K: TO K053269. DEVICE EVALUATED BY MANUFACTURER? "YES." DEVICE MANUFACTURE DATE TO 10/07/2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD-57 AND THE RAINBOW SENSOR SOMETIMES SHOWS HIGH LEVEL OF CO ALTHOUGH THE PATIENT HASN'T INHALED CO. THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD-8 UNIT WILL JUST TURN OFF EVEN WHEN PLUGGED IN OR FULLY CHARGED. THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69208 RAD-8 OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1