BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-GEL RESUS PACK 4

    MDR report key: 19373610 · Received May 21, 2024

    Report

    Report Number
    MW5155214
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 19, 2024
    Report Date
    May 19, 2024
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BEGAN SUFFERING UPPER AIRWAY BLEEDING DURING A CARDIAC ARREST RESUSCITATION FOLLOWING PLACEMENT AND USE OF AN IGEL SUPRAGLOTTIC AIRWAY. AN EXPERIENCED PROVIDER (17 YEARS AS A PARAMEDIC) WITH HUNDREDS OF OUT OF HOSPITAL CARDIAC ARRESTS ATTENDED AND HUNDREDS OF IGEL PLACEMENTS INSERTED A NUMBER 4 IGEL, PLACED VIA MANUFACTURER INSTRUCTION, LUBRICATED WITH SUPPLIED WATER-BASED LUBRICANT, SECURED WITH SUPPLIED ELASTIC GREEN STRAP. A BAG MASK WAS ATTACHED TO THE PATIENT AND VENTILATION GIVEN DURING RESUSCITATION WITH CARDIOPULMONARY RESUSCITATION DURING THE 30 MINUTES AND MULTIPLE DEFIBRILLATION ATTEMPTS. BRIGHT RED BLOOD BEGAN FILLING THE IGEL AFTER APPROXIMATELY 28 MINUTES INTO THE RESUSCITATION, AND THIS INCREASED IN VOLUME DURING TRANSPORT UNTIL IGEL WAS REMOVED AT HOSPITAL AND REPLACED WITH ENDOTRACHEAL TUBE. TOTAL TIME OF PREHOSPITAL CARE APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305040 I-GEL RESUS PACK 4 AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY CAE INTERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other ALBUTEROL.| ASPIRIN. | ATORVASTATIN.| CARVEDILOL.| FLUOXETINE.| INSULIN.| LASIX.