MAUDE Adverse Event Report: SUNMED FOR VENT LABS LLC. VENT LABS LLC.; 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER

Model Number	HS4011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 18 jun 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, the endotracheal tube was attached to a bagged patient when they noticed part of the clear plastic part of the manometer piece was broken.It was replaced with another device; there was no reported injury.
Additional Manufacturer Narrative
Correction: d9 additional information-investigation completion: d4; h2; h3; h4; h6.The actual sample from the reported event was returned for evaluation.Testing of the sample confirmed the event as reported; however, the root cause is undetermined.The device history record for lot: 240500437 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 nov 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 complaint: (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, the endotracheal tube was attached to a bagged patient when they noticed part of the clear plastic part of the manometer piece was broken.It was replaced with another device; there was no reported injury.

• Brand Name: VENT LABS LLC.
• Common Device Name: 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER
• Manufacturer (Section D): SUNMED FOR VENT LABS LLC.; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): SUN MED FOR VENT LAB LLC; 2710 northridge dr. nw,; suite a; grand rapids MI 49544
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22286410
• Report Number: 1314417-2025-00038
• Device Sequence Number: 8922041
• Product Code: NHK
• UDI-Device Identifier: 10889483110850
• UDI-Public: (01)10889483110850(10)240500437(11)240513
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: HS4011
• Device Lot Number: 240500437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown