BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR-Q3

    MDR report key: 21647806 · Received March 19, 2025

    Report

    Report Number
    1314417-2025-00012
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 10, 2025
    Report Date
    August 5, 2025
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CAE
    UDI-DI
    10889483480731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G1; H11; AIR LIFE BECAME AWARE OF THE COMPLAINT ON 18FEB2025. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 05 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 19 MAR 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PROVIDER INSERTED THE AIRWAY DEVICE AND SECURED [IT] AS INSTRUCTED; FOUND AIRWAY DEVICE TO HAVE TWISTED OUT OF THE SECUREMENT DEVICE AND LOST SEAL. THE SEAL WAS CONFIRMED BY END TIDAL CARBON DIOXIDE (ETCO2) READINGS THAT WERE BOUNCING AROUND DURING TRANSPORT. UPON TRANSFER TO THE HOSPITAL STAFF, NO SEAL FROM THE DEVICE WAS FOUND.IT WAS ADDITIONALLY REPORTED, THE AIR-Q SP3G WAS TWISTING AND SLIPPED OUT OF THE THOMAS SELECT TUBE HOLDER. THIS CAUSED A LOSS OF SEAL IN THE AIRWAY DURING TRANSPORT. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PROVIDER INSERTED THE AIRWAY DEVICE AND SECURED [IT] AS INSTRUCTED; FOUND AIRWAY DEVICE TO HAVE TWISTED OUT OF THE SECUREMENT DEVICE AND LOST SEAL. THE SEAL WAS CONFIRMED BY END TIDAL CARBON DIOXIDE (ETCO2) READINGS THAT WERE BOUNCING AROUND DURING TRANSPORT. UPON TRANSFER TO THE HOSPITAL STAFF, NO SEAL FROM THE DEVICE WAS FOUND. IT WAS ADDITIONALLY REPORTED, THE AIR-Q SP3G WAS TWISTING AND SLIPPED OUT OF THE THOMAS SELECT TUBE HOLDER. THIS CAUSED A LOSS OF SEAL IN THE AIRWAY DURING TRANSPORT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453395 AIR-Q3 AIR-Q3 SELF PRESSURIZING ILA WITH AUTOMATIC CUFF INFLATION AND GA SIZE 5.0 CAE SUNMED HOLDINGS LLC 60505 UNKNOWN 10889483480731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown