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

Model Number	BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the boxed pat circuit assy,3100a,fltrd,850l is extremely pliable and bendy which has implications with flow on the oscillator and often stops the oscillator.It happened during use, and the patient became bradycardic and had to be manually ventilated.Tubing needed to be put back on/replaced and secured with a tape.
Additional Manufacturer Narrative
The customer sent a picture for evaluation however, the reported issue if the tube or component were soft or malleable was not confirmed.A sample is needed to perform a better investigation looking for any issue with the resin.Therefore the root cause was not determined.In addition pfmea 10a was reviewed and we have controls for this kind of issue.The issue occurred with three patients.Please refer to (b)(4) for the other two patients.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Common Device Name: 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: 13791230
• Report Number: 8030673-2022-00233
• Device Sequence Number: 16595674
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820(10)0004179629
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Device Catalogue Number: 29028-011
• Device Lot Number: 0004179629
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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