MAUDE Adverse Event Report: Ventlab LLC Ventlab; Small Adult bag, mask w/ inflat bag res, filter & peep

Model Number	AF5040MBP
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• Brand Name: Ventlab
• Common Device Name: Small Adult bag, mask w/ inflat bag res, filter & peep
• Manufacturer (Section D): Ventlab LLC; 2710 northridge dr. nw,; suite a; grand rapids MI 49544
• Manufacturer (Section G): Productos Urologos de Mexico S.A. de C.V.; cerrada via de la produccion; no. 85 parque industrial; baja california, mexicali MI 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw; suite a; grand rapids, MI 49544
• MDR Report Key: 25855314
• Report Number: 1314417-2026-00048
• Device Sequence Number: 12152216
• Product Code: BTM
• UDI-Device Identifier: 10889483161074
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K012842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AF5040MBP
• Device Catalogue Number: AF5040MBP
• Device Lot Number: 0004334671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown