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

Model Number	PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the defective device has not been returned for evaluation.Therefore the root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 29657-001- patient circuit w/o peep, 22 mm spu (10/pkg) was leaking air around a proximal port when connected to the ventilator, causing the ventilator to lock up.The defective circuit was replaced and the customer confirmed that there was no harm associated with the reported event.
Additional Manufacturer Narrative
Result of the investigation: the device history record for the part number 29657-001 with lot number 0004140206 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released on 29apr2021 per our internal procedures and no issues were found.Based on the investigation and per sample sent by the customer, we could not confirm the defect, sample was visually inspected and no issue were found, also sample was leak tested and no leak was found, those inspections were performed according to pqas 10818x10 etal.Therefore the root cause was not determined.In addition pfmea -35a was reviewed and we have the controls for this kind of issues.

• Brand Name: PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USECBK
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12775034
• Report Number: 8030673-2021-00212
• Device Sequence Number: 3485576
• Product Code: CBK
• UDI-Device Identifier: 10190752115934
• UDI-Public: (01)10190752115934(10)0004140206
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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, 22 MM SPU (10/PKG)
• Device Catalogue Number: 29657-001
• Device Lot Number: 0004140206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown