BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX DOC-10

    MDR report key: 2919873 · Received January 11, 2013

    Report

    Report Number
    2936999-2013-00032
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED STATED THAT DOC10 CABLE LOT NUMBER WAS UNKNOWN AND THAT THE CABLE HAD BEEN THROWN AWAY. THEREFORE, THE DATE OF MFR CANNOT BE DETERMINED. CUSTOMER LETTER HAS BEEN SENT CONTAINING DIRECTIONS FOR USE GUIDELINES. PER OXIMAX DOC-10 DIRECTIONS FOR USE: DESCRIPTION/INTENDED USE: THE DOC CABLE IS FOR USE ONLY WITH NELLCOR OXYGEN SENSORS THAT HAVE A SLOT ON BOTH SIDES OF THE PLUG. INSTRUCTIONS FOR USE: USE ONLY NLY NELLCOR OXYGEN SENSORS THAT HAVE BOTH SIDES OF THE CONNECTING PLUG SLOTTED. WHEN CONNECTING THE SENSOR TO THE CABLE, ALWAYS ORIENT THE SENSOR PLUG SO THAT NELLCOR IS VISIBLE. CLEANING: CLEAN THE CABLE BY WIPING IT WITH ISOPROPYL ALCOHOL. WARNINGS: EXAMINE CABLE BEFORE USE. DO NOT USE A DAMAGED CABLE OR ONE WITH EXPOSED WIRES. CAUTIONS. DO NOT STERILIZE. THIS CABLE IS NOT DESIGNED FOR STERILIZATION, INCLUDING IRRADIATION, OR EXPOSURE TO STEAM OR ETHYLENE OXIDE. DO NOT IMMERSE THE CABLE IN CLEANING SOLUTIONS, DISINFECTING SOLUTIONS, OR WATER. DAMAGE TO THE CABLE CAN RESULT. WHEN DISCONNECTING THE CABLE FROM THE MONITOR, ALWAYS DEPRESS THE BUTTONS ON BOTH SIDES OF THE CONNECTOR AS IT IS REMOVED FROM THE MONITOR SOCKET. TO AVOID DAMAGING THE DOC, GRASP THE CONNECTOR RATHER THAN THE CABLE WHEN DISCONNECTING IT FROM THE SENSOR OR FROM THE MONITOR. CHECK CABLE CONNECTIONS. FAILURE TO PROPERLY CONNECT THE PLUGS WILL RESULT IN INTERMITTENT READINGS OR NO READINGS.

    Description of Event or Problem · 1

    BIOMED REPORTED TO COVIDIEN THAT ON (B)(6) 2012, A N600X WAS GIVING LOW READINGS. ON (B)(6) 2012, BIOMED STATED THAT LOW READINGS HAD BEEN ISOLATED TO THE DOC10 CABLE. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16626 OXIMAX DOC-10 PULSE OXIMETRY CABLE DPZ COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 N600X