BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRONICS

    MDR report key: 1613113 · Received February 5, 2010

    Report

    Report Number
    2183646-2010-00001
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    November 24, 2009
    Report Date
    February 24, 2010
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K893221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, THE 8000AA ADULT ARTICULATED FINGER CLIP SENSOR IS DESIGNED FOR SPOT CHECKING OR DATA COLLECTION OF ADULT OR ADOLESCENT PTS, WHERE LITTLE SENSOR MOTION IS EXPECTED. INSTRUCTIONS FOR USE CAUTIONS OPERATOR TO INSPECT THE SENSOR APPLICATION SITE AT LEAST EVERY 6 TO 8 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PT SENSITIVITY TO SENSORS MAY VARY DUE TO MEDICAL STATUS ON SKIN CONDITION.

    Description of Event or Problem · 1

    (B)(6) ALLEGES THAT THE FIRST FINGER OF HER RIGHT HAND WAS BURNED WHILE USING THE EQUIPMENT. (B)(6) REPORTED THAT SHE PLACED THE PROBE ON THE POINTER FINGER OF HER RIGHT HAND BEFORE GOING TO BED ON THE NIGHT OF (B)(6) 2009. SHE STATED SHE FELT THAT IT WAS "HOT" FOR ABOUT 25-30 SECONDS, AND THEN THE SENSATION WENT AWAY. SHE FURTHER REPORTED SHE WOKE UP 3 HOURS LATER AND TOOK OFF THE PROBE AND NOTED A BLISTER ON HER FINGER. THE NEXT MORNING, SHE STATED SHE FELT A BURNING SENSATION AT THE SITE AND RAN COLD WATER OVER THE SITE AND APPLIED ICE TO HER FINGER. SHE REPORTS HAVING THE BLISTER FOR APPROX 2-3 DAYS AND THEN THE BLISTER POPPED. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS MODEL 920M PULSE OXIMETER WITH 936 SENSO DQA NONIN MEDICAL, INC. 920M, 936 SENSOR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other