BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 4932641 · Received July 17, 2015

    Report

    Report Number
    2031172-2015-00948
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING THIS TESTING THE UNIT WAS FOUND TO HAVE AN OPEN SPEAKER. THE SPEAKER WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE UNIT HAS LOOSE PARTS INSIDE THE DEVICE, AND ALSO STATES THAT THE ALARM SOUND FUNNY. ADDITIONAL INFORMATION RECEIVED THE CUSTOMER MENTIONED NO ERROR CODES OR MESSAGES WAS OBSERVED, AND THE DISPLAY WORKED FINE. THE CUSTOMER ALSO STATED THE SPEAKER SOUNDS DISTORTED OR MUFFLED. THERE WAS NO KNOWN PATIENT IMPACT OR CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465120 RAD-8 OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1