BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURAFLEX

    MDR report key: 11998684 · Received June 15, 2021

    Report

    Report Number
    1220828-2021-00003
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    November 17, 2020
    Report Date
    February 2, 2021
    Manufacturer
    AMBU A/S
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AMBU HAS BECOME AWARE OF 5 CASES OF HYPOXIA ARISING DURING THE USE OF AURAFLEX. ALL FIVE CASES OCCURED ON THE SAME CHILDRENS HOSPITAL IN (B)(6). THE CUSTOMER COMPLAINED THAT THE MATERIAL OF THE AURAFLEX TUBE IS TOO HARD COMPARED WITH COMPETITOR DEVICES, AND THAT THIS CAUSES THE LARYNGEAL MASK TO MOVE BACKWARDS CAUSING AIR LEAKAGE AND POOR VENTILATION. NO SAMPLE OR PICTURES WERE AVAILABLE FOR INVESTIGATION. THE HARDNESS OF THE AURAFLEX TUBE IS DESIGNED TO ENSURE THAT THE TUBE DOES NOT KINK OR COMPRESS AND TO MAKE HANDLING AND INSERTION OF THE TUBE EASIER. PER THE CUSTOMER COMPLAINT THE AIR LEAKAGE HAPPENED BECAUSE THE AURAFLEX MOVED BACKWARDS, WHEN THE DOCTOR RELEASED THEIR HANDS AFTER INSERTING THE TUBE. IT IS REQUIRED IN THE AURAFLEX INSTRUCTION FOR USE TO FIXATE THE DEVICE TO THE PATIENT FACE IN CASE OF ANY MOVEMENT. THIS IS THE FIRST COMPLAINT ON AURAFLEX RELATED TO DESATURATION OF A PATIENT. AMBU INC. DOES NOT DISTRIBUTE OR MARKET THIS DEVICE (327300000) IN THE US. THIS MDR IS RESUBMITTED AGAIN AS IT WAS IDENTIFIED THAT ORIGINAL SUBMISSION HAD NOT BEEN SUCCESSFULLY LOADED INTO THE FDA DATABASE DUE TO WRONG FILE FORMAT. THE INITIAL MDR OF THIS INCIDENT WAS SUBMITTED TO THE FDA WITHIN THE ORIGINAL REPORTING DEADLINE. THIS SUBMISSION REPRESENTS A RELOAD OF DATA TO ENSURE CORRECT UPLOAD TO THE FDA DATABASE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT THE CATHETER MATERIAL OF THE AURAFLEX IS TOO HARD COMPARED TO COMPETITOR DEVICES. THIS CAUSES THE LARYNX MASK TO MOVE BACKWARDS AFTER RELEASING THE HANDS CAUSING AIR LEAKAGE AND POOR VENTILATION. THIS HAS RESULTED IN HYPOXIA IN 5 CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897928 AURAFLEX LARYNGEAL MASK; OROPHARYNGEAL CAE AMBU A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention