BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5V HANDHELD

    MDR report key: 4913366 · Received July 10, 2015

    Report

    Report Number
    2031172-2015-00921
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K033998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVAL IT WAS FOUND THAT SOME OF THE LED SEGMENTS DO NO ILLUMINATE. SIGNIFICANT CORROSION/CONTAMINATION WAS FOUND ON THE SYSTEM BOARD. THE SYSTEM BOARD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: 06/11/2015. BRAND NAME: RAD-5V HANDHELD. (B)(4). MODEL # 20763 , CATALOG # 1705. PMA 510(K) : K033998. MFG DATE) : 12/18/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER OBSERVED THE TOP LED DISPLAY IS MISSING SEGMENTS. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448584 RAD-5V HANDHELD OXIMETER DQA MASIMO CORPORATION 20763

    Patients

    Seq Age Sex Outcome Treatment
    1