BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO SET INTELLIVUE MODULE

    MDR report key: 6038784 · Received October 19, 2016

    Report

    Report Number
    2031172-2016-01134
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 22, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K040259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION WHEN BENDING/MOVING THE MODULE SENSOR CONNECTOR, THE SIGNAL WAS INTERMITTENTLY LOST OR NOISY. IT WAS FOUND THAT THE MODULE SENSOR CONNECTOR FAILED DUE TO AN OPEN WIRE CONTINUITY AT PIN 3 AND THE MOTHER BOARD SOLDER POINT WHEN THE CONNECTOR WAS FLEXED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER NINE (9) YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTELLIVUE MODULE COULD NOT MEASURE DUE TO CONTACT FAILURE WITH THE CABLE. SOMETIMES THE DISPLAY SIGNAL IS NORMAL AND SOMETIMES THE SIGNAL IS LOST OR NOISY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693642 MASIMO SET INTELLIVUE MODULE OXIMETER DQA MASIMO - 40 PARKER 1846

    Patients

    Seq Age Sex Outcome Treatment
    1