MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not send physical sample and pictures since the sample used due to supply needs.Therefore, no root cause could 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
It was reported to vyaire medical that many of their adu320x4d - anes circuit, adult, 108 in exp, 3l bag have been coming in without any air in the mask or with very little air.They are all deflated.This can cause problems in the case of emergencies.The customer confirmed that there was no patient harm/injury associated with the event.

• Brand Name: VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16639536
• Report Number: 8030673-2023-00307
• Device Sequence Number: 17802625
• Product Code: BTM
• UDI-Device Identifier: 10190752121522
• UDI-Public: (01)10190752121522(10)0004241323
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Device Catalogue Number: ADU320X4D
• Device Lot Number: 0004241323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/29/2023
• 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
• Patient Sex: Unknown