BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRAP SENSOR

    MDR report key: 43212 · Received October 17, 1996

    Report

    Report Number
    MW1010080
    Event Type
    Malfunction
    Date Received
    October 17, 1996
    Report Date
    October 10, 1996
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE WRAP SENSOR HAS A PROTECTIVE SHEATH WHICH COVERS THE FIBEROPTIC WHICH IS A VERY THIN RUBBER. THESE SHEATHS ARE EASILY TORN. THE MOST VULNERABLE PART OF THE DEVICE HAS THE LEAST AMOUNT OF PROTECTION. THE END OF THE SENSOR WHERE THE FIBEROPTIC LIGHT ILLUMINATES IS ALSO EASILY TORN WITH DAILY USE. HOSP CLINICAL ENGINEERS HAVE EXAMINED THE DAMAGED SENSORS AND DEEMED THEM "UNREPAIRABLE" DUE TO MFR DEFECT. THE DEVICE IS WARRANTED FOR 90 DAYS. AFTER 90 DAYS IF THE DEVICE BECOMES DAMAGED YOU HAVE NO ALTERNATIVE BUT TO PURCHASE A NEW DEVICE. PRICE $1500.00. THIS DEVICE MUST BE USED IN THE MRI ENVIRONMENT TO ELIMINATE THE POSSIBILITY OF A "BURN" WHICH HAS OCCURRED WITH CONVENTIONAL PULSE OXIMETRY DEVICES AND SENSORS. THIS DEVICE SHOULD BE REDESIGNED TO INCREASE ITS LIFE EXPECTANCY AS WELL AS RELIABILITY. ONCE THE SHEATH OR SENSOR IS DAMAGED IT WILL FAIL. IT WILL NOT SENSE THE PULSE RATE OR 02 SATURATION. SENSOR WAS PLACED ON A PT, 10/8/96, AND IT FAILED. THE MONITOR READ "LOW LIGHT" SAME DAY CLINICAL ENGINEERS TESTED THE SENSOR WITH TWO (2) DIFFERENT MONITORS AND DEEMED THE SENSOR DAMAGED, NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRAP SENSOR PULSE OXIMETER DQA INVIVO RESEARCH, INC. 9399 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *