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

Device Problem Mechanical Problem (1384)

Patient Problem Pneumothorax (2012)

Event Date 09/12/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 282406092
• Report Number: 8030673-2021-00210
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10885403272134
• UDI-Public: (01)10885403272134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812273
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/13/2021
• 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
• Patient Outcome(s): Required Intervention