BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU KING LTS-D

    MDR report key: 7568769 · Received June 4, 2018

    Report

    Report Number
    MW5077625
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    February 26, 2018
    Report Date
    June 3, 2018
    Manufacturer
    AMBU INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT: CUFF FAILURE. MED (B)(6) REPORTED A CUFF FAILURE IN A SIZE 4 KING AIRWAY PLACED DURING A RESUSCITATION ATTEMPT. KING CUFF WAS TESTED WITH 50-60 CC AIR PRIOR TO INTUBATION (AFTER REMOVAL OF NOTED PROTECTIVE END CAP). PT HAD ONGOING VOMITING AND SECRETIONS. NG WAS PLACED THROUGH THE SUCTION LUMEN. A FEW MOMENTS LATER, THE FLUIDS WERE SPRAYING FROM THE NASAL PHARYNX. ATTEMPT TO RE-INFLATE UNSUCCESSFUL - CUFF WOULD HOLD AIR AND APPEARED TO RUPTURE. KING AIRWAYS WAS REMOVED AND A NEW KING 4 WAS PLACED WITHOUT INCIDENT. DATES OF USE: 10 MINUTES. DIAGNOSIS OR REASON FOR USE: RESPIRATORY ARREST. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408415 AMBU KING LTS-D DISPOSABLE LARYNGEAL TUBE BTR AMBU INC. KING LTS-D SIZE 4

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention