BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS ADTX ADHESIVE SENSOR

    MDR report key: 3817595 · Received April 18, 2014

    Report

    Report Number
    2031172-2014-00043
    Event Type
    Other
    Date Received
    April 18, 2014
    Date of Event
    February 8, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADD'L INFO PERTINENT TO THE EVENT HAVE BEEN MADE. THE CUSTOMER HAS INDICATED THAT THEY NO LONGER HAVE THE SENSOR AVAILABLE FOR EVAL AND THE SENSOR LOT NUMBER IS UNK. RISK MANAGEMENT PERSONNEL INFORMED MASIMO THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT "THE PT IS DOING FINE".

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: "NURSE WAS CHARGING IN THE ICU UNIT. SHE WAS ASKED TO TAKE A CALL FROM A PT WHO HAD BEEN ADMITTED TO THE ICU THE PREVIOUS WEEK. NURSE SPOKE WITH THE PT WHO IDENTIFIED HIMSELF AS A PREVIOUS ICU PT WHO ADMITTED A BOUT A WEEK BEFORE AND DISCHARGED THE NEXT DAY. HE STATED HE HAD WHAT HE THOUGHT WAS A BURN ON HIS FINGER. HE STATED HE NOTICED IT AFTER THE PULSE OXIMETER TAPING WAS REMOVED FROM HIS FINGER. HE WAS GETTING READY TO DISCHARGE AND HE STATED HE MENTIONED IT TO THE NURSE WHO WAS DISCHARGING HIM, HE STATED THAT NOW IT WAS EIGHT DAYS LATER AND HIS FINGER WAS A DARKER COLOR, IT WAS HARD AND NUMB. HE STATED IT LOOKED LIKE A BURN BLISTER OR BLOOD BLISTER ON HIS FINGER WHERE THE PULSE OXIMETER WAS PRESENT. HE SAID HE WAS A WELDER BY TRADE AND THIS BLISTER WAS AFFECTING HIS ABILITY TO WORK AS A WELDER. THE RISK DEPARTMENT HAS SINCE BEEN IN TOUCH WITH THE PT. HE DOES NOT FEEL THIS IS AN ALLERGY TO THE ADHESIVE ON THE OXIMETER THAT WAS WRAPPED AROUND HIS FINGER AS HE STATES THE REACTION/BLISTER IS ONLY ON THE PAD OF HIS RIGHT INDEX FINGER. HE IS A DIABETIC AND WAS ACTUALLY ADMITTED FOR DKA. HE DID NOT HAVE ANY COMPLAINTS OF BURNING OR THE MONITOR BEING TOO TIGHT BUT REPORTS A BLOOD BLISTER TYPE REACTION. HE SAID AT THE TIME OF DISCHARGE WHEN THIS WAS REMOVED, IT LOOKED LIKE HE WAS BURNED OR HAD A BLISTER. UNFORTUNATELY, THE DISPOSABLE PULSE OXIMETER FINGER SENSOR WAS NOT SAVED. THEREFORE THE ACTUAL LOT NUMBER AND EXPIRATION DATE IS NOT KNOWN. NURSING PERSONNEL HAVE STATED THEY HAVE NOT SEEN THIS TYPE OF SENSOR BURN BEFORE". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238706 LNCS ADTX ADHESIVE SENSOR DQA MASIMO CORPORATION LNCS ADTX

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other