MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA; HYPERINFLATION BAG SYSTEM

Model Number	VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned for evaluation.No photos available.Therefore, no root cause has been 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
The customer reported that the vital signs¿ flow inflating tail-end valve transport circuit, flow-inflating tra experienced valve closes too easily which caused high pressures to enter lungs and resulted in pneumothorax.As an intervention, intubated infant being given manual breaths.

• Brand Name: VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA
• Common Device Name: HYPERINFLATION BAG SYSTEM
• 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: 12788935
• Report Number: 8030673-2021-00210
• Device Sequence Number: 4840313
• Product Code: BTM
• UDI-Device Identifier: 10885403272134
• UDI-Public: (01)10885403272134
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K812273
• 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): 10/13/2021

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: VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA
• Device Catalogue Number: 5102RVW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/10/2021
• 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