MAUDE Adverse Event Report: VENTLAB LLC VENTLAB; HYPER ELBOW W/MANOMETER

Model Number	HS40000
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): hyperinflation.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 16 jan 2025 has been included in the 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 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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
Received mdr medwatch report from fda reporting that an adult unit code blue on intubated patient.Attempting to bag/ventilate patient.Pressure release valve was not functioning properly.The bag hyperinflated regardless of positioning of valve through entire spectrum of its dialing.Could not properly deliver ventilation to patient until second bag was brought in.It was determined this is a reportable event for 1 incident.
Event or Problem Description
Received mdr medwatch report from fda reporting that an adult unit code blue on intubated patient.Attempting to bag/ventilate patient.Pressure release valve was not functioning properly.The bag hyperinflated regardless of positioning of valve through entire spectrum of its dialing.Could not properly deliver ventilation to patient until second bag was brought in.It was determined this is a reportable event for 1 incident.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): hyperinflation.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 16 jan 2025 has been included in the 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 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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.The reported complaint complaint-(b)(4) stated that "adult unit code blue on intubated patient.Attempting to bag/ventilate patient.The pressure release valve was not functioning properly.The bag hyperinflated regardless of positioning of valve through entire spectrum of its dialing.Could not properly deliver ventilation to patient until second bag was brought in".The complaint history was reviewed in grand avenue from dates of january 1st, 2023, to december 31, 2024, for part number hs4030-w for failure mode "functional issue(s)." this is the third complaint reported for part number hs4030-w.An email was sent to the customer on january 13, 2025, requesting additional information regarding part number hs4030-w hyperinflation system.On january 22, 2025, the customer responded with minimal details, stating they had no further information on the pressure setting, thumbwheel condition, or potential obstructions.Additionally, no physical sample, photos, or videos were provided, and no patient harm was reported.On february 11, 2025, an email was sent to the customer inquiring whether the product had been disposed of.On (b)(6) 2025, the customer confirmed that the product had been disposed of.The device history record (dhr) review for part number hs4030-w and lot number 230700410 confirmed that no abnormal processing issues were identified.All products and packaging were produced following approved procedures, specifications, and inspections.No conclusions were able to be reached based on the investigation.The complaint has been entered into elg-20026-c1 as elg-0081.The complaint history was reviewed in grand avenue from dates of december 17, 2022, to december 17, 2024, for part number hs4030-w for failure mode "functional issue(s)." this is the third complaint reported specifically for part number hs4030-w.A customer resolution letter was sent.We will continue monitoring trends during periodic complaint review meetings.

• Brand Name: VENTLAB
• Common Device Name: HYPER ELBOW W/MANOMETER
• Manufacturer (Section D): VENTLAB LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21172660
• Report Number: 1314417-2025-00001
• Device Sequence Number: 18494945
• Product Code: NHK
• UDI-Device Identifier: 10889483084823
• UDI-Public: (01)10889483084823(10)230700410
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HS40000
• Device Catalogue Number: HS40000
• Device Lot Number: 230700410
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2400100000-2024-8023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown