MAUDE Adverse Event Report: VENTLAB, LLC VENTLAB; RESUSCITATOR,MANUAL,NON SELF-INFLATING

Model Number	HS4011
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 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: RESUSCITATOR,MANUAL,NON SELF-INFLATING
• Manufacturer (Section D): VENTLAB, LLC; 2710 northridge drive nw, suite a; grand rapids MI 49544
• MDR Report Key: 17975566
• Report Number: 17975566
• Device Sequence Number: 2491712
• Product Code: NHK
• UDI-Device Identifier: 10889483110850
• UDI-Public: (01)10889483110850(11)220802(10)220800081
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2023
• Report Date (Section F): 09/22/2023

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: Other
• Device Model Number: HS4011
• Device Lot Number: 220800081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2023
• 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
• Date Report Sent to FDA: 09/22/2023