MAUDE Adverse Event Report: VENTLAB LLC VENTLAB; AIRFLOW ADULT RESUSCITATOR WITH BAG RESERVOIR, GAS SAMPLING LINE, AND MASK

Model Number	AF5000MB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a code blue event, the nurse removed the bag valve mask (bvm) from the crash cart and found it broken into multiple pieces.The registered nurse had to obtain another bvm, resulting in a delay in patient care.Due to quality assurance (qa) requirements, staff do not want to break the taped seal on the bag.Additionally, the color of the bag prevents visual inspection of the bvm, limiting the ability to verify the device's condition during routine crash cart checks.
Additional Manufacturer Narrative
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 23 apr 2026 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 airlife represents all of the information known 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 airlife.Airlife has no independent knowledge of the event reported but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the airlife 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 airlife product was defective or caused serious injury.

• Brand Name: VENTLAB
• Common Device Name: AIRFLOW ADULT RESUSCITATOR WITH BAG RESERVOIR, GAS SAMPLING LINE, AND MASK
• Manufacturer (Section D): VENTLAB LLC; 2710 northridge dr. nw,; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED MANUFACTURED FOR VENTLAB, LLC; 2710 northridge dr. nw,; suite a; grand rapids MI 49544
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw; suite a; grand rapids, MI 49544
• MDR Report Key: 24975166
• Report Number: 1314417-2026-00025
• Device Sequence Number: 4915862
• Product Code: BTM
• UDI-Device Identifier: 10889483073346
• UDI-Public: (01)10889483073346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/15/2026

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: AF5000MB
• Device Catalogue Number: AF5000MB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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