BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4250084 · Received August 22, 2013

    Report

    Report Number
    2031172-2014-00146
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 22, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COMMUNICATION FAILURE BETWEEN THE HANDHELD AND DOCKING STATION. THE DOCKING INDICATOR REPEATEDLY TURNED OFF AND ON. INFO WAS LATER PROVIDED TO MASIMO THAT ALL FIVE INDICATORS ON THE RDS WERE BLINKING IN A TWO TO THREE SECOND CYCLE, AND THE DEVICE WAS CONNECTED WITH A PHILIPS MONITOR AND NO ERROR OR ALARM IS SHOWN ON THE DISPLAY WHEN THE COMMUNICATION FAILURE OCCURS. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409216 RADICAL-7 HANDHELD DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1