BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRO

    MDR report key: 23107146 · Received September 22, 2025

    Report

    Report Number
    3014054118-2023-00002
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    March 10, 2023
    Report Date
    September 17, 2025
    Manufacturer
    FOGLESS INTERNATIONAL AB
    Product Code
    JOH
    PMA / PMN Number
    K122932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE A MALFUNCTION OF THE SPIRO SPEAKING VALVE. THE USER FAILED TO FOLLOW THE MANUFACTURER'S LABELLING, INCLUDING A CAUTION SYMBOL PRINTED ON THE DEVICE, AND THE BOLD WARNING TEXT IN THE INSTRUCTIONS FOR USE "NEVER PLACE A SPEAKING VALVE ON A TRACHEAL CANNULA THAT HAS AN INFLATED CUFF AND IS NOT FENESTRATED".

    Description of Event or Problem · 0

    CONFUSION WITH A SPEAKING VALVE AND HEAT MOISTURE EXCHANGER. THE SPEAKING VALVE WAS PLACED ON NON-FENESTRATED CUFFED CANNULA. RESULT: BRADYCARDIA. INTERVENTION: SPEAKING VALVE REPLACED WITH HEAT MOISTURE EXCHANGER - THE PATIENT QUICKLY SATURATES TO 95 THEN 98% UNDER 15L OF OXYGEN - PLACEMENT OF A 20F CHEST DRAIN WITH SIGNIFICANT AIR RELEASE DURING PLACEMENT - RESUMPTION OF MECHANICAL VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655203 SPIRO SPEAKING VALVE WITH OXYGEN NIPPLE JOH FOGLESS INTERNATIONAL AB 710 5377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R