MAUDE Adverse Event Report: VENTLAB LLC VENTLAB; 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER

Model Number	HS4011
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The bag was leaking air.  the patient in the pacu required support with breathing.The crna requested a bag valve mask and received a 1l hyperinflation system + manometer from ventlab (sunmed).After hooking up the oxygen the crna attempted ventilation and noticed the bag leaking.On inspection, the inflation bag had several small cuts that prevented good ventilation.A replacement (same product) was quickly obtained and the patient was treated without harm.
Additional Manufacturer Narrative
The patient in the pacu required support with breathing.The crna requested a bag valve mask and received a hyperinflation.After hooking up the oxygen the crna attempted ventilation and noticed the bag leaking.On inspection, the inflation bag had several small cuts that prevented good ventilation.A replacement was quickly obtained, and the patient was treated without harm.This would delay therapy.
Additional Manufacturer Narrative
The patient in the pacu required support with breathing.The crna requested a bag valve mask and received a hyperinflation.After hooking up the oxygen the crna attempted ventilation and noticed the bag leaking.On inspection, the inflation bag had several small cuts that prevented good ventilation.A replacement was quickly obtained, and the patient was treated without harm.This would delay therapy the complaint of the bag was leaking air (and had several small cuts).Regarding part number hs4011 /lot 220800081 was unable to be confirmed.There was no returned product, pictures or video to evaluate.The device history record (dhr) review showed no abnormal processing issues noted related to this complaint during manufacturing.Generally, visible cuts can be detected during the visual inspection which is a 100% check; however, very tiny cuts may escape this inspection.There were no "cut" issues mentioned in the dhr for this complaint lot.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board; the capa was entered in the capa escalation log.There has been one (1) other complaint ((b)(4)) regarding the same part and similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.Udi related data quality updates.
Event or Problem Description
The bag was leaking air.The patient in the pacu required support with breathing.The crna requested a bag valve mask and received a 1l hyperinflation system + manometer from ventlab (sunmed).After hooking up the oxygen the crna attempted ventilation and noticed the bag leaking.On inspection, the inflation bag had several small cuts that prevented good ventilation.A replacement (same product) was quickly obtained and the patient was treated without harm.

• Brand Name: VENTLAB
• Common Device Name: 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER
• Manufacturer (Section D): VENTLAB LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB 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: 18165397
• Report Number: 1314417-2023-00026
• Device Sequence Number: 6646677
• Product Code: NHK
• UDI-Device Identifier: 10889483110850
• UDI-Public: (01)10889483110850(10)220800081
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Catalogue Number: HS4011
• Device Lot Number: 220800081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown