MAUDE Adverse Event Report: VYAIRE MEDICAL OY T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	M1091335VS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Following patient delivery, team attempting to give patient positive end-expiratory pressure (peep) through t-piece resuscitator in neo room.Per report, provider unable to achieve peep greater than 7 and had instances of losing peep during patient care.Of note - this has been reportedly happening with this product recently and cns (reporter) is working with product rep.And supply chain to investigate potential product change or defects affecting use of product.

• Brand Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL OY; 510 technology dr.; irvine CA 92618
• MDR Report Key: 16060740
• Report Number: 16060740
• Device Sequence Number: 2033373
• Product Code: BTL
• UDI-Device Identifier: 10190752135680
• UDI-Public: 10190752135680
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/02/2022
• Report Date (Section F): 12/02/2022

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: M1091335VS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2022
• 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: 12/02/2022