BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 23846178 · Received December 18, 2025

    Report

    Report Number
    1314417-2025-00105
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Report Date
    December 18, 2025
    Manufacturer
    VENT LAB LLC
    Product Code
    BTM
    UDI-DI
    10889483565643
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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 18 DEC 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 (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 1314417-2025-00104 FOR THE FIRST REPORT. IT WAS REPORTED, DURING A RESPIRATORY CALL, THE MEDICAL DIRECTOR ATTEMPTED TO USE THE CAPNO-LINE, PACKAGED WITH THE BAG VALVE MASK (BVM), AND NOTED IT DID NOT PROVIDE ANY READINGS. THE LINE WAS DISCONNECTED AND RECONNECTED WITH AN ADDED EXTRA TWIST; HOWEVER, IT STILL DID NOT PROVIDE ANY READINGS. THE LINE WAS SWITCHED TO A NEW DEVICE, WHICH WORKED IMMEDIATELY. THE LACK OF READING HINDERED PATIENT CARE AND DELAYED TREATMENT ON SCENE; HOWEVER, IT WAS NOTED THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386307 AIRFLOW AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER BTM VENT LAB LLC AF2142MBS-45E UNKNOWN 10889483565643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown