BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN MODEL 8004CB

    MDR report key: 4392264 · Received December 12, 2014

    Report

    Report Number
    2183646-2014-00005
    Event Type
    Other
    Date Received
    December 12, 2014
    Date of Event
    November 2, 2014
    Report Date
    December 10, 2014
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL CAUSES FOR THIS ALLEGED INCIDENT ARE LABELLED FOR IN OUR INSTRUCTIONS FOR USE. THESE INSTRUCTIONS MAY NOT HAVE BEEN FOLLOWED RESULTING IN THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    THE ALLEGED REPORT IS OF A PATIENT INJURY STATED AS "CAUSED "BURNS" ON PATIENTS FOREHEAD. (B)(4). THIS WAS A (B)(6) FEMALE PATIENT IN FOR TETROLOGY OF FALLOT REPAIR, WITH TWO SENSORS PLACED ON THE FOREHEAD IN THE USUAL MANNER IN THE CVOR PRIOR TO THE SURGICAL REPAIR. THEY CLEAN THE FOREHEAD WITH A WATER WIPE OR SALINE WIPE, DRY THE FOREHEAD AND PLACE SENSORS, THEY DO NOT USE AN ALCOHOL PREP. ROUTINE LENGTH OF MONITORING IS DURING THE SURGICAL PROCEDURE UNTIL EXTUBATION, IN THIS CASE THE MONITORING TIME WAS APPROXIMATELY 23 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811403 NONIN MODEL 8004CB OXIMETER DQA NONIN MEDICAL INC. 8004CB 33528

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other