BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5V PULSE OXIMETER

    MDR report key: 4200881 · Received September 17, 2014

    Report

    Report Number
    2031172-2014-00193
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING AN INSPECTION OF THE INSIDE OF THE DEVICE, THE UNIT WAS FOUND TO HAVE HAD LIQUID INGRESS. A SERVICE HISTORY REVIEW RESULTS THAT THIS UNIT WAS IN THE FIELD FOR OVER 4 YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. A REVIEW OF THE LABELING WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE NUMERIC DISPLAY IS MISSING LED SEGMENTS. NO PT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577194 RAD-5V PULSE OXIMETER OXIMETER DQA MASIMO CORPORATION 9196

    Patients

    Seq Age Sex Outcome Treatment
    1