BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE RANGER MONITOR ASSEMBLY

    MDR report key: 5632801 · Received May 4, 2016

    Report

    Report Number
    9615393-2016-00206
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS RECEIVED FOR EVALUATION AND THE REPORTED FAILURES OF THE SCREEN FLICKERS AND HAZY IMAGES COULD NOT BE DUPLICATED. TECH SERVICES PLUGGED A TEST RANGER GVL 4 INTO THE MONITOR AND POWER IT ON. THE IMAGE WAS GOOD. THE CABLE WAS WIGGLED AND FLEXED WITH NO RESULT. THE MONITOR WAS CLEANED AND RETESTED AND PASSED THE IMAGE PATTERN QUALITY TEST. THE DEVICE WAS RETURNED TO THE LOANER POOL. THIS MDR IS BEING FILED AS RESULT OF A RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE RANGER MONITOR ASSEMBLY, THE SCREEN FAILED; IT FLICKERED ON AND OFF DURING A SCHEDULED INTUBATION. ALSO THE SCREEN WAS HAZY SO IT WAS DIFFICULT TO SEE EVEN WHEN THE MONITOR WASN'T FLICKERING. AS A RESULT THE EQUIPMENT WAS NOT USED AND DIRECT LARYNGOSCOPY WAS EMPLOYED. BECAUSE OF THIS, A DELAY IN THE PROCEDURE OF UNKNOWN DURATION OCCURRED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285169 GLIDESCOPE RANGER MONITOR ASSEMBLY LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0186

    Patients

    Seq Age Sex Outcome Treatment
    1