MAUDE Adverse Event Report: VYAIRE MEDICAL BOXED PATIENT CIRCUIT ASSY, 3100A, 850L; VENTILATOR, HIGH FREQUENCY

Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850L

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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 the 29028-004 description boxed patient circuit assy, 3100a, 850l is extremely pliable and bend which has implications with flow on the oscillator and often stops the oscillator.Lung de-recruitment occurred as an intervention, circuit was replaced with the new one to enable oscillation to continue.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13261988
• MDR Text Key: 288195842
• Report Number: 8030673-2022-00229
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752155259
• UDI-Public: (01)50190752155259(10)0004155821
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2021

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
• Device Operator: Health Professional
• Device Model Number: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Device Catalogue Number: 29028-004
• Device Lot Number: 0004155821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/14/2022
• 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