BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5 HANDHELD

    MDR report key: 4161822 · Received July 24, 2014

    Report

    Report Number
    2031172-2014-00120
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K033296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED WHICH INCLUDED FUNCTIONAL TESTING. DURING THIS TESTING THE UNIT PROVIDED BOTH AUDIBLE AND VISUAL ALARMS. AN INTERNAL INSPECTION OF THE DEVICE WAS CONDUCTED AND THE UNIT WAS CONFIRMED TO HAVE A SPEAKER PRODUCING A LOW VOLUME. THE UNIT WAS ALSO FOUND TO HAVE CORROSION ON THE SYSTEM BOARD. A REVIEW OF THE DEVICE LABELING WAS PERFORMED. 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) YEARS 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 SPEAKER VOLUME IS VERY LOW AND THEY ARE UNABLE TO INCREASE IT. NO PATIENT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433064 RAD-5 HANDHELD DQA DQA MASIMO CORPORATION 9196

    Patients

    Seq Age Sex Outcome Treatment
    1