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

Model Number	M2M, ASSY PAT CIR W/O PEEP ADT SPU 10PK
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3:02-the suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.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 item 29657-001 circuit patient adult w/o peep valve 22mm spu dehp-free is faulty for use in the hospital.There are leaks in the circuits causing low volumes.No patient involvement was reported.
Additional Manufacturer Narrative
H3: finding/root-cause: unable to verify or duplicate the reported complaint.Uut is functional.Disposition: assy, patient circuit w/o peep adt spu 10pk p/n:29657-001 l/n:0004261360 will be scrapped.
Event or Problem Description
Additional information received indicates that the customer was able to return their devices for further investigation.Unfortunately they were unable to verify or duplicate the reported complaint.

• Brand Name: PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 19052206
• Report Number: 2021710-2024-18972
• Device Sequence Number: 7339038
• Product Code: CBK
• UDI-Device Identifier: 10190752115934
• UDI-Public: (01)10190752115934(10)0004261360
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: M2M, ASSY PAT CIR W/O PEEP ADT SPU 10PK
• Device Catalogue Number: 29657-001
• Device Lot Number: 0004261360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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
• Patient Sex: Unknown