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

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 312413673
• Report Number: 8030673-2023-00307
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10190752121522
• UDI-Public: (01)10190752121522(10)0004241323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1