BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVL COBALT GLIDESCOPE

    MDR report key: 7556343 · Received May 31, 2018

    Report

    Report Number
    7556343
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 24, 2018
    Manufacturer
    VERATHON INC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GLIDESCOPE CABLE/SCREEN NOT FUNCTIONING PROPERLY. UNABLE TO USE FOR POSSIBLE TRAUMA ALERT INTUBATION. SMART CABLE: REF: (B)(4). E-MAILED CLIENT(S) UPDATE. CABLE WILL BE OVER-NIGHTED. SENDING OLD CABLE BACK. PER RESPIRATORY THERAPIST (RT), THE PATIENT WAS STABILIZED AND INTUBATION WAS NOT NEEDED. RT WAS ATTEMPTING TO SET IT UP BECAUSE WHEN THE PATIENT FIRST CAME IN IT APPEARED WE MIGHT NEED TO INTUBATE, BUT WE DID NOT. NO HARM CAME TO THE PATIENT. MANUFACTURER: VERATHON INC., MODEL: AVL COBALT GLIDESCOPE. SENDING BACK OLD CABLE, NEW CABLE OVERNIGHTED. DEVICE BACK TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400253 AVL COBALT GLIDESCOPE LARYNGOSCOPE, RIGID CCW VERATHON INC

    Patients

    Seq Age Sex Outcome Treatment
    1