BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS PC, INC-10-GE, CABLE

    MDR report key: 4554298 · Received February 19, 2015

    Report

    Report Number
    2031172-2015-00284
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 23, 2015
    Report Date
    January 23, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K101896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, "MASIMO SPO2 IN GE OEM DEVICE (GAS MACHINE MONITOR) IN SPINAL ROOM SHOWS INACCURATE READING WHEN SPINAL SURGERY OCCURS. SPECIAL IMAGING USED. OTHER ROOMS DO NOT SHOW THIS BEHAVIOR. ONE INCIDENT SHOWED DESATURATION INTO THE 70S PROMPTING THE ANESTHESIOLOGIST TO PERFORM A VISUALIZATION OF THE ENDOTRACHEAL TUBE." NO KNOWN IMPACT OR CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120696 LNCS PC, INC-10-GE, CABLE OXIMETER DQA MASIMO CORPORATION 2016 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1