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

Model Number	PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not available for returned for evaluation.Therefore, root cause has not been determined yet.But the device history record will be reviewed in order to detect any issue related with the reported defect during its manufacturing.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) stop working after just five minutes of using, resulted to patients increase respiratory rate to forty breaths per minute and the patient cannot breath.As an intervention, the circuit replaced with a backup device.
Additional Manufacturer Narrative
The device history record for the part number 29657-001 with lot number 0004153862 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 20jul2020 per our internal procedures and no issues were found.Based on the investigation since no sample or picture were provided for the investigation, we were unable to confirm the reported defect.Samples or pictures are needed to perform a better investigation.Therefore the root cause was not determined.The pfmea 35a was reviewed and we have the controls for this kind of issues.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 14215364
• Report Number: 8030673-2022-00240
• Device Sequence Number: 5308380
• Product Code: CBK
• UDI-Device Identifier: 10190752115934
• UDI-Public: (01)10190752115934(10)0004153862
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 0004153862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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