MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. LTV PATIENT CIRCUIT W/O PEEP, 22MM, SPU; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	29657-001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient circuit w/o peep (positive end-expiratory pressure), 22mm, spu----unable to ventilate patients due to leaks in the system.This has happened on several occasions.

• Brand Name: LTV PATIENT CIRCUIT W/O PEEP, 22MM, SPU
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 19018498
• Report Number: 19018498
• Device Sequence Number: 18127487
• Product Code: CBK
• UDI-Device Identifier: 10190752115934
• UDI-Public: (01)10190752115934
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/11/2024
• Report Date (Section F): 03/11/2024

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
• Device Model Number: 29657-001
• Device Catalogue Number: 29657-001
• Device Lot Number: 0004261360
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/11/2024