BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL 7 COLOR SCREEN

    MDR report key: 4189191 · Received October 1, 2014

    Report

    Report Number
    2031172-2014-00220
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K100428
    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 EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE OFF SYMPTOM OCCURRED DURING THE SET-UP BEFORE CLINICAL USE. THE SENSOR WAS NOT APPLIED TO FINGER, BUT SPO2 INDICATED 100%. THE UNIT WAS CONNECTED TO A NIHON KOHDEN MONITOR. HEALTHCARE WORKERS TRIED TO EXCHANGE TO ANOTHER HANDHELD, DRC-1, AND RED LNC-10. ALSO, THEY TRIED TO REBOOT THE HANDHELD, BUT THE SYMPTOM WAS NOT RESOLVED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610084 RADICAL 7 COLOR SCREEN OXIMETER DQA MASIMO CORPORATION 23789

    Patients

    Seq Age Sex Outcome Treatment
    1