BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXIMAX MAX-FAST FOREHEAD SENSOR

    MDR report key: 737327 · Received July 6, 2006

    Report

    Report Number
    2936999-2006-00670
    Event Type
    Other
    Date Received
    July 6, 2006
    Date of Event
    June 20, 2006
    Report Date
    July 6, 2006
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SENSOR WAS REQUESTED BACK, BUT WAS SCRAPPED ALONG WITH THE HEADBAND, AND NOW IS UNAVAILABLE FOR EVALUATION. THE MANUFACTUER'S DFU (DIRECTIONS FOR USE) RECOMMENDED THAT THE SITE BE CHANGED EVERY 12 HOURS, MORE OFTEN FOR PATIENTS WITH POOR PERFUSION. THE MAX-FAST DFU WAS SENT BY NELLCOR PURITAN BENNETT AND HAS BEEN RECEIVED BY THE MEDICAL CENTER.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT CONTACTED A USER FACILITY REGARDING A SKIN INTEGRITY ISSUE WITH THE OXIMAX MAX-FAST FOREHEAD 02 SENSOR. AN ELDERLY PATIENT IN THE USER FACILITY'S CARDIAC ICU EXPERIENCED A 'SKIN BREAKDOWN' AT THE SENSOR SITE. THE MAX-FAST AND HEADBAND HAVE BEEN PLACED ON THE SAME SITE FOR THREE (3) DAYS, WITHOUT ANY SITE CHANGES. THERE WAS NO MEDICAL TREATMENT GIVEN TO THE PATIENT FOR THE SKIN BREAKDOWN. THE PATIENT HAD SINCE EXPIRED, AND THE NURSE STATED, THAT THIS WAS 'NOT DUE TO THE SKIN BREAKDOWN. THIS WAS DUE TO THE PATIENT'S CARDIAC STATUS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX MAX-FAST FOREHEAD SENSOR ADHESIVE OXYGEN SENSOR DQA NELLCOR PURITAN BENNETT MAX-FAST UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other