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

Model Number	BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).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 or Problem Description
The customer reported that the boxed patient circuit assy, 3100a, 850l is extremely pliable and bend which obstructs the flow on the oscillator and often stops it from working.The issue is often associated with the tubing that is connected to the humidifier.The customer stated that they have had 5 of the same issue.The oscillator turned off and they tried to restart it but to no avail.They called in a member of the staff who noticed that a part was popped off by the humidifier.They called tech team, put the tubing back on and placed a tape over the tubing to keep it in place.There is no patient information.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14795028
• Report Number: 8030673-2022-00256
• Device Sequence Number: 14660588
• Product Code: LSZ
• UDI-Device Identifier: 50190752155259
• UDI-Public: (01)50190752155259(10)0004155821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/23/2022
• 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