BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO/ADULT OXY SENSOR MODEL MAX N

    MDR report key: 4081137 · Received September 5, 2014

    Report

    Report Number
    2936999-2014-00801
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    PMA / PMN Number
    K052186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURNED FOR EVAL. IT IS UNK WHAT THE WEIGHT OF THE CHILD IS. THE LOT NUMBER IS UNK, SO THE MFR DATE IS UNK. THE SENSOR WAS TRANSFERRED TO THE LAB IN THE HOSPITAL AND INVESTIGATION WAS DONE. IT WAS CONCLUDED THAT THERE WAS NO PROBLEM ON THE SENSOR ITSELF. PER OXIMAX MAX-N DIRECTIONS FOR USE: INDICATIONS/CONTRAINDICATIONS. THE NELLCOR OXIMAX NEONATAL/'ADULT OXYGEN SENSOR, MODEL MAX-N, IS INDICATED FOR SINGLE PT USE WHEN CONTINUOUS NONINVASIVE ARTERIAL OXYGEN SATURATION AND PULSE RATE MONITORING ARE REQUIRED FOR NEONATES WEIGHING LESS THAN 3 KG OR ADULTS WEIGHING MORE THAN 40 KG.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A FEMALE PT (4 MONTHS OLD) HAD MRI ON (B)(6). SHE HAD OXI-SENSOR ON HER RIGHT THUMB FOR OXIMETER SETUP. AFTER MRI, THE NURSE CONNECTED OXI-SENSOR WITH THE MONITOR BUT SPO2 AND HR MEASUREMENTS DID NOT DISPLAY. WHEN SHE WAS CHECKING THE SENSOR TO FIGURE OUT THE CAUSE, SHE FOUND THE DISCOLORATION (FROM BURNING) ON PT'S RIGHT THUMB. THE PT HAD AN ARM BOARD ON HER RIGHT HAD TO FIX IV SITE. THE PROXIMAL PART OF THE PT'S THUMB HAD A DISCOLORATION AND IT WAS NOT RIGID LIKE A NORMAL FINGER. THE DISTAL PART OF THE THUMB (CLOSE TO THE NAIL AND THE KNUCKLE), WHERE THE OXI-SENSOR WAS WRAPPED, TURNED INTO A REDISH-BLUE COLOR. THERE WAS NO EDEMA ON THE IV SITE. PROFESSOR USED A BLADE 11 TO CHECK THE CIRCULATION AND DID A MILD INCISION ON THE THUMB. THERE WAS NO BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543267 NEO/ADULT OXY SENSOR MODEL MAX N MAX-N OXYGEN SENSOR DQA COVIDIEN MAX-N

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention