BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS DCI ADT REUSABLE SENSOR

    MDR report key: 4213221 · Received October 1, 2014

    Report

    Report Number
    2031172-2014-00218
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR TWENTY (20) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    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 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 SYSTEM WAS NOT RESOLVED. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612031 LNCS DCI ADT REUSABLE SENSOR OXIMETER DQA MASIMO CORPORATION 1863-1 12NYV

    Patients

    Seq Age Sex Outcome Treatment
    1