BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB

    MDR report key: 23045586 · Received September 12, 2025

    Report

    Report Number
    1314417-2025-00069
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 12, 2025
    Manufacturer
    VENT LAB LLC
    Product Code
    BTM
    UDI-DI
    10889483085783
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE, FROM THE REPORTED EVENT WAS RETURNED AND EVALUATED, NO ISSUES WERE OBSERVED ON DEVICE. SINCE THE REPORTED FAILURE WAS NOT REPRODUCED IN THE LAB DURING SAMPLE EVALUATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 472176 WAS REVIEWED; THERE WAS NO EQUIPMENT IN PLACE TO ENSURE OR DETECT VACUUM-RELATED FAILURES. AS A RESULT, THE ENGINEERING TEAM HAS IMPLEMENTED PRESSURE TESTERS FOR THE PATIENT VALVE ACROSS ALL RESUS PRODUCTS. ALL INFORMATION REASONABLY KNOWN AS OF 12 SEP 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 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: UNABLE TO OBTAIN CHEST RISE DURING USE BY EXPERIENCED STAFF FOR THE INFANT WHO WAS IN NEED OF URGENT INTUBATION; THE CHILD BAG WAS USED INSTEAD; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2651251 VENTLAB AIRFLOW INFANT RESUSCITATOR WITH 40CM POP-OFF, B/V FILTER, BAG RESERVOIR, AND MA BTM VENT LAB LLC AF3040MB 472176 10889483085783

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Unknown