BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCM

    MDR report key: 1750797 · Received February 26, 2010

    Report

    Report Number
    3002807968-2010-00002
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    August 24, 2009
    Report Date
    February 3, 2010
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K043003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SEEN BY ONE OF THE HOSPITAL DAY TECHNICIANS DURING THE LAST WEEK OF (B) (6) 2009 AND COMPLAINED OF A BURN SHE RECEIVED DURING A SLEEP STUDY THAT WAS PERFORMED (B) (6) 2009. THE HOSPITAL EXPLAINED THAT SHE MAY HAVE WORN THE PROBE FOR JUST OVER EIGHT HOURS, A LONGER PERIOD THAN WHAT IS DESCRIBED IN THE OPERATOR'S MANUAL. THE HOSPITAL STAFF HAD PREVIOUS TRAINING AND ARE AWARE THAT THEY MUST MOVE THE ELECTRODE EVERY 4 HOURS. RETRAINING HAS BEEN OFFERED AND IS EXPECTED TO OCCUR. PER THE WARNINGS AND CAUTIONS SECTION IN THE OPERATOR'S MANUAL: DO NOT ALLOW THE ELECTRODE TEMPERATURE TO EXCEED 43 DEGREES C FOR NEONATES AND 44 DEGREES C FOR ADULTS WHEN ELECTRODES ARE ATTACHED TO SKIN FOR MORE THAN FOUR HOURS. SENSORS MUST BE MOVED TO A NEW SITE AT LEAST EVERY FOUR HOURS. BECAUSE INDIVIDUAL SKIN CONDITION AFFECTS THE ABILITY OF THE SKIN TO TOLERATE SENSOR PLACEMENT, IT MAY BE NECESSARY TO CHANGE THE SENSOR SITE MORE FREQUENTLY WITH SOME PATIENTS. IF SKIN INTEGRITY CHANGES, MOVE THE SENSOR TO ANOTHER SITE. ONE OF THE MONITORS WAS SENT IN FOR AN EVALUATION, AND IT WAS FOUND TO BE FUNCTIONING PROPERLY (TO SPECIFICATION). THERE IS NO INDICATION THAT THE MONITOR FAILED AT ANY TIME. SINCE THE CUSTOMER WAS UNAWARE OF WHICH MONITOR WAS INVOLVED IN THE INCIDENT, THE REMAINING THREE MONITORS WILL BE EVALUATED ON SITE BY RADIOMETER REPRESENTATIVE TO VERIFY PROPER OPERATION.

    Description of Event or Problem · 1

    ON (B) (6)2010, AN E-MAIL WAS SENT TO A LOCAL SALES REPRESENTATIVE REPORTING THE FOLLOWING: DURING A SLEEP STUDY, THE PATIENT WAS MONITORED USING A TRANSCUTANEOUS MONITORING DEVICE AND SUFFERED A BURN TO THE UPPER CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCM TCM4 LKD RADIOMETER MEDICAL APS TCM4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention