MAUDE Adverse Event Report: VENT LAB LLC VENTLAB; AIRFLOW INFANT RESUSCITATOR WITH 40CM POP-OFF, B/V FILTER, BAG RESERVOIR, AND MA

Model Number	AF3040MB
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: VENTLAB
• Common Device Name: AIRFLOW INFANT RESUSCITATOR WITH 40CM POP-OFF, B/V FILTER, BAG RESERVOIR, AND MA
• Manufacturer (Section D): VENT LAB LLC; 2710 northridge dr. nw,; suite a; grand rapids MI
• Manufacturer (Section G): SUN MED FOR VENT LAB LLC; 2710 northridge dr. nw,; suite a; grand rapids MI
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23045586
• Report Number: 1314417-2025-00069
• Device Sequence Number: 9849635
• Product Code: BTM
• UDI-Device Identifier: 10889483085783
• UDI-Public: (01)10889483085783(10)472176(11)240213(17)290213
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: AF3040MB
• Device Lot Number: 472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 6 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG