BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 6024704 · Received October 12, 2016

    Report

    Report Number
    2031172-2016-01126
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 20, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): CORRECTED DATA: (MFR REPORT NUMBER) UPDATED FROM 2031172-2016-01382 TO 2031172-2016-01126.

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVAL, THE DEVICE WAS UNABLE TO POWER ON USING THE RETURNED BATTERY. USING A KNOWN GOOD BATTERY, THE RETURNED 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "SWINGING VALUES" ON MULTIPLE RAD-8 UNITS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673356 RAD-8 OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1