BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB

    MDR report key: 22615581 · Received July 25, 2025

    Report

    Report Number
    1314417-2025-00053
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Report Date
    June 26, 2025
    Manufacturer
    VENT LAB LLC
    Product Code
    BTM
    UDI-DI
    10889483161074
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (B)(6) 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, THE RESUSCITATION BAG BROKE APART AS THEY WERE PLACING IT ON THE PATIENT, WHO WAS CODING; ANOTHER BAG WAS USED AS THIS ONE WAS UNABLE TO PROVIDE POSITIVE PRESSURE. THERE WAS A SLIGHT DELAY IN RESUSCITATION; HOWEVER, THE STAFF WAS ABLE TO GIVE THE PATIENT O2 BY HOLDING THE BAG TOGETHER, UNTIL ANOTHER BAG WAS PROCURED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846240 VENTLAB SMALL ADULT BAG, MASK W/ INFLAT BAG RES, FILTER & PEEP BTM VENT LAB LLC AF5040MBP UNKNOWN 10889483161074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown