BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL

    MDR report key: 4213235 · Received October 2, 2014

    Report

    Report Number
    2031172-2014-00224
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K061204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED. NO PT INCIDENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNS OFF WHEN THE DOCKING STATION IS UNPLUGGED. THE CUSTOMER TRIED WITH MULTIPLE DOCKING STATIONS. THE CUSTOMER HAS REPLACED THE BATTERY WITH A KNOWN GOOD BATTERY. THERE WERE NO ERROR MESSAGES DISPLAYED PRIOR TO SHUT OFF. THE UNIT WILL MONITOR PATIENTS NORMALLY UNTIL SHUT OFF. NO PT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617218 RADICAL OXIMETER DQA MASIMO CORPORATION 1309

    Patients

    Seq Age Sex Outcome Treatment
    1