BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE AVL MONITOR GLIDESCOPE AVL MONITOR

    MDR report key: 6604400 · Received June 1, 2017

    Report

    Report Number
    9615393-2017-00094
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 5, 2017
    Report Date
    June 1, 2017
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVL MONITOR RETURNED TO VERATHON FOR EVALUATION. TECHNICAL SERVICES COULD NOT CONFIRM THE REPORTED LOSS OF VIDEO IMAGE. THE AVL MONITOR WAS POWERED ON AND OFF SEVERAL TIMES WITH A TEST VIDEO BATON ATTACHED AND THE IMAGE WAS DISPLAYED AND REMAINED VISIBLE. THE AVL MONITOR WAS LEFT POWERED ON FOR ONE (1) HOUR WITH THE TEST BATON ATTACHED. THE CABLE OF THE VIDEO BATON WAS MANIPULATED EVERY TEN (10) MINUTES WITH NO LOSS OF VIDEO DETECTED. HOWEVER, IT WAS NOTED THE IMAGE ON THE AVL MONITOR WAS SHIFTING. THE VIDEO SHIFTING WAS ISOLATED TO THE DIGITAL CORE PCBA. THE DIGITAL CORE PCBA WAS REPLACED AND THE AVL MONITOR PASSED ALL VIDEO TESTS AND WAS RETURNED TO THE CUSTOMER. CORRECTIVE ACTION IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT AND THE PRODUCT HAS NOT YET BEEN RECEIVED FOR EVALUATION. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SERIAL NUMBER, (B)(4), IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED ON 06/01/2011 AND THE ONE (1) YEAR WARRANTY PERIOD HAS EXPIRED. SHOULD THE DEVICE BE RETURNED, THE DEVICE EVALUATION DATA WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE AVL MONITOR, THE VIDEO MONITOR LOST THE VIDEO IMAGE AND IT RETURNED SEVERAL SECONDS LATER. NO DELAY IN THE PROCEDURE OR USE OF A BACK-UP DEVICE WAS REPORTED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386728 GLIDESCOPE AVL MONITOR GLIDESCOPE AVL MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0304 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1