BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KING VISION VIDEO LARYNGOSCOPE

    MDR report key: 7788878 · Received August 15, 2018

    Report

    Report Number
    MW5079168
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 8, 2018
    Report Date
    August 14, 2018
    Manufacturer
    AMBU / KING SYSTEMS
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED WITHOUT WARNING DURING USE WHILE ATTEMPTING ENDOTRACHEAL INTUBATION OF A PT IN CARDIAC ARREST. DATES OF USE: 5 YEARS. DIAGNOSIS OR REASON FOR USE: VIDEO ASSISTED ENDOTRACHEAL INTUBATION. IS THE PRODUCT COMPOUNDED: NO; IS THE PRODUCT OVER-THE-COUNTER: NO. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626553 KING VISION VIDEO LARYNGOSCOPE LARYNGOSCOPE KIT OGH AMBU / KING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening