BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1012667 · Received March 11, 2008

    Report

    Report Number
    1056128-2008-00013
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 25, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NLF
    PMA / PMN Number
    K042316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED ONE WIRE AND HAD BEEN PULLED AWAY FROM THE SENSOR, REVEALING A SINGLE STRAND OF NON-CURRENT-CARRYING (EMI SHIELDING) WIRE. EXCESSIVE TENSILE FORCE APPLIED TO THE WIRES OF THE SENSOR CAN CAUSE THE WIRES AND WIRE INSULATION TO PULL AWAY FROM THE SENSOR. VISUAL EXAMINATION ALSO REVEALED THAT THE SENSOR HAD BEEN MODIFIED BY THE USER WITH EXCESS TAPE BEING PLACED AROUND THE SENSOR AND WIRES. THE INSTRUCTIONS FOR USE PROVIDED SPECIFICALLY STATE NOT TO "ATTEMPT TO REPAIR, MODIFY OR CLEAN THE SENSOR." THIS EVIDENCE SUGGESTS THAT THE DEVICE WAS MISUSED, ALTHOUGH NO CONCLUSION COULD BE DEFINITIVELY DRAWN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINOR BURN WAS OBSERVED ON THE PATIENT'S TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLF ASCENT HEALTHCARE SOLUTIONS MAX-N 154591

    Patients

    Seq Age Sex Outcome Treatment
    1