BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPU DIGITAL RECORDING SYSTEM 1080P

    MDR report key: 6486051 · Received April 12, 2017

    Report

    Report Number
    1017294-2017-00035
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 12, 2017
    Manufacturer
    MED X CHANGE, INC
    Product Code
    LMB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER MED X CHANGE IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE USER FACILITY CONTACTED THE CONMED SALES REPRESENTATIVE TO REPORT A FIRE IN THEIR OPERATING ROOM ON (B)(6) 2017. IT WAS REPORTED THAT ABOUT MID-CASE DURING A GYN PROCEDURE THE DVD DRIVE OF THE CPU DIGITAL RECORDING SYSTEM 1080P WAS OBSERVED TO BE SMOLDERING/SMOKING AND HAD TO BE UNPLUGGED AND REMOVED FROM THE ROOM. THE FIRE DEPARTMENT WAS CALLED. THE PROCEDURE WAS COMPLETED USING ANOTHER CPU DIGITAL RECORDING SYSTEM 1080P. THERE WAS NO PATIENT OR STAFF INJURY REPORTED. A 15-MINUTE DELAY WAS REPORTED DURING THE SURGERY DUE TO THE ALLEGED MALFUNCTION AND THE NEED TO REMOVE THE UNIT FROM THE ROOM AND SET UP ANOTHER RECORDING SYSTEM. AS REPORTED, WHEN THE FIRE DEPARTMENT ARRIVED AT THE USER FACILITY, THE ALLEGED SMOLDERING/SMOKING FROM THE DVD DRIVE HAD CEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269869 CPU DIGITAL RECORDING SYSTEM 1080P DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL LMB MED X CHANGE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1