BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO

    MDR report key: 3783852 · Received April 4, 2014

    Report

    Report Number
    2031172-2014-00033
    Event Type
    Other
    Date Received
    April 4, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY INDICATED THAT THE SENSOR DID NOT MALFUNCTION. THE USER FACILITY DID NOT MAKE THE SENSOR AVAILABLE FOR EVAL DESPITE REQUESTS FOR RETURN OF THE PRODUCT. THE SERIAL NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS DEVICE MET ALL RELEASE CRITERIA. INFO WAS MADE AVAILABLE TO MASIMO THAT THE CARE PROVIDER MISIDENTIFIED THE CABLE/SENSOR WITH THE CHEST TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "NURSE ATTENDING TO NEONATE NOTED THAT SHE HAD CONFUSED THE CHEST TUBE WITH THE PULSE OXIMETRY SENSOR CABLE, SINCE THEY BOTH LOOKED THE SAME. NURSE WAS CONCERNED SHE COULD HAVE TUGGED ON THE CHEST TUBE, PULLING IT OUT OF POSITION, THINKING THAT IT WAS THE PULSE OXIMETRY SENSOR CABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205485 LNCS NEO DQA MASIMO CORPORATION LNCS NEO K13N46

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PERCUTANEOUS| FUHRMAN PLEAURAL| PNEUMOPERICARDIAL DRAINAGE TRAY-CATHETER