MAUDE Adverse Event Report: VENT LAB LLC VENTLAB; AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER

Model Number	AF2142MC
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: air was not flowing through the bag, the respiratory therapist (rt) put water into [the bag] to test it; water leaked out of the lower portion of the bag.This resulted in delay in treatment as they had to open up another bag; however, there was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence did not confirm the complaint as reported.The device history record for lot 533733 was reviewed and the product was produced according to product specifications.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.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence did not confirm the complaint as reported.The device history record for lot 533733 was reviewed and the product was produced according to product specifications.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: air was not flowing through the bag, the respiratory therapist (rt) put water into [the bag] to test it; water leaked out of the lower portion of the bag.This resulted in delay in treatment as they had to open up another bag; however, there was no reported injury.

• Brand Name: VENTLAB
• Common Device Name: AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER
• 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: 23045531
• Report Number: 1314417-2025-00070
• Device Sequence Number: 13177322
• Product Code: BTM
• UDI-Device Identifier: 10889483081181
• UDI-Public: (01)10889483081181(10)533733(17)300130(11)250130
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: AF2142MC
• Device Lot Number: 533733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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