BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1904409 · Received November 22, 2010

    Report

    Report Number
    1056128-2010-00084
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ASCENT
    Product Code
    NLF
    PMA / PMN Number
    K081238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE SHOWED THE DEVICE WAS RECEIVED WITHOUT THE TAPE THAT IS APPLIED DURING REPROCESSING BY ASCENT AND WITHOUT THE TAPE THAT IS APPLIED DURING MANUFACTURING BY THE ORIGINAL EQUIPMENT MANUFACTURER WHICH IS NOT REMOVED BY ASCENT DURING REPROCESSING. THE DEVICE WAS MISSING THE OPTICAL COMPONENTS AS WELL AND THERE WAS EVIDENCE OF ADHESIVE RESIDUE ON THE DISTAL END OF THE DEVICE CABLING. PULL FORCE TESTING WAS PERFORMED ON A NEW REPROCESSED DEVICE. THE RESULTS OF THE TESTING SHOWED THE RETURNED DEVICE WAS SUBJECTED TO CONDITIONS BEYOND ITS INTENDED USE BASED ON THE CONDITION OF THE DEVICE INVOLVED IN THE PULL TEST. INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED ISSUE CONFIRMED THE DEVICE WAS USED ON AN INFANT AND THE PROBE WAS ROTATED ON DIFFERENT FINGERS FOR 12 HOURS. ACCORDING TO ASCENT'S INSTRUCTIONS FOR USE (IFU), DEVICE MODEL 2329 IS AN ADULT O2 TRANSDUCER POX SENSOR DESIGNED FOR USE ON THE FINGER OF PATIENTS >40KG. ASCENT'S IFU ALSO STATES: PRIOR TO USE, READ AND FOLLOW THESE INSTRUCTIONS AS WELL AS THOSE OF THE OPERATORS MANUAL FOR YOUR PULSE OXIMETRY SYSTEM. DO NOT USE IF THERE IS ANY EVIDENCE OF DAMAGE TO THE PACKAGE. INSPECT THE SENSOR FOR VISIBLE DEFECTS. NEVER USE A SENSOR WITH EXPOSED ELECTRICAL CIRCUITRY OR ONE THAT APPEARS TO BE DAMAGED. CAREFULLY ROUTE CABLE AND PATIENT CABLE TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION. DO NOT USE A SENSOR OR PULSE OXIMETER CABLE IF IT IS DAMAGE AND/OR IF OPTICAL COMPONENTS ARE EXPOSED. INSPECT THE SENSOR SITE PERIODICALLY TO ENSURE CORRECT SENSOR ALIGNMENT AND ADHESION. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE OXYGEN SATURATION PROBE CAME APART IN TWO PIECES. THE WIRES AT THE END OF THE PROBE WERE EXPOSED. THE WIRED PORTION WAS FOUND IN THE HAND OF THE 11 MONTH OLD PATIENT." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLF NLF ASCENT 2329 1259602

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO