BEUDAMED
    FDA Adverse Event Summary report: N

    SURGICAL MONITOR

    MDR report key: 6095915 · Received November 11, 2016

    Report

    Report Number
    1000404456-2016-00010
    Date Received
    November 11, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 11, 2016
    Manufacturer
    STERIS CORPORATION - VTS MEDICAL SYSTEMS
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL MONITOR. WHILE THE TECHNICIAN WAS PRESENT AND DURING HIS INSPECTION, HE OBSERVED THAT ONE OF THE MONITORS BEGAN TO EMIT SMOKE AT THE TOP OF THE UNIT. THE TECHNICIAN DISCONNECTED THE POWER TO THE MONITOR AND REMOVED THE UNIT FROM SERVICE. THE MONITOR WAS REPLACED AND THE UNIT WAS RETURNED TO SERVICE. FOLLOWING THE REPLACEMENT OF THE MONITOR, THE IMAGE DISPLAYED ON THE MONITOR BEGAN TO "FLICKER" DURING A PATIENT PROCEDURE. A STERIS SERVICE TECHNICIAN INSPECTED THE REPLACEMENT MONITOR AND FOUND THE POWER CABLES WITHIN THE MONITOR SUPPORT ARM WERE DAMAGED SPECIFICALLY, MARKS ON THE INSULATION AND EXPOSED WIRES. THE DAMAGED POWER CABLES CAUSED THE REPORTED SMOKE OBSERVED BY THE TECHNICIAN DURING HIS FIRST INSPECTION AND IMAGE QUALITY ON THE REPLACEMENT MONITOR. THE TECHNICIAN MADE REPAIRS TO THE POWER CORDS WITHIN THE SUPPORT ARM AND PROVIDED MORE SLACK WITHIN THE SUPPORT ARM TO PREVENT REOCCURRING DAMAGE. THE TECHNICIAN RETURNED THE UNIT TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR SURGICAL MONITOR WAS NOT OPERATING PROPERLY. NO REPORT OF INJURY OR PROCEDURE DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748074 SURGICAL MONITOR SURGICAL MONITOR KQM STERIS CORPORATION - VTS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1