MAUDE Adverse Event Report: VYAIRE MEDICAL PATIENT CIRCUIT W/O PEEP W/WATER TRAP, 22 MM SPU (10/PKG); VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	PATIENT CIRCUIT W/O PEEP W/WATER TRAP, 22 MM SPU (10/PKG)
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample nor pictures available for evaluation.The customer has declined to provide email.Therefore, no root cause can be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the patient circuit w/o peep w/water trap, 22 mm spu (10/pkg) experienced getting connection error.Found the part that connects to vent was defected or incorrect connection.The customer confirmed that there was no patient harm associated with the reported event.As an intervention, they replaced the sample and it was resolved.

• Brand Name: PATIENT CIRCUIT W/O PEEP W/WATER TRAP, 22 MM SPU (10/PKG)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12490590
• Report Number: 8030673-2021-00195
• Device Sequence Number: 3735694
• Product Code: CBK
• UDI-Device Identifier: 10190752115989
• UDI-Public: (01)10190752115989(11)20200909(10)0004160466
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: PATIENT CIRCUIT W/O PEEP W/WATER TRAP, 22 MM SPU (10/PKG)
• Device Catalogue Number: 29663-001
• Device Lot Number: 0004160466
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention