BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED LNC-10 PATIENT CABLE

    MDR report key: 4213219 · Received October 1, 2014

    Report

    Report Number
    2031172-2014-00217
    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 RETURNED CABLE WAS EVALUATED. DURING EVALUATION THE CABLE PASSED ALL FUNCTIONAL TESTING. THE CABLE 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 SYMPTOM WAS NOT RESOLVED. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613226 RED LNC-10 PATIENT CABLE OXIMETER DQA MASIMO CORPORATION 21502 A12N043

    Patients

    Seq Age Sex Outcome Treatment
    1