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

Model Number	BOXED PATIENT CIRCUIT ASSY, 3100A, 850SL
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.The issue occurred with three patients.Please see (b)(4) for the other two.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, 850s (hose) came loose from the coupling piece that connects back to the humidification chamber of the f&p.As such, the hfo (high frequency oscillation) stopped.The hose was reinserted, fixed with brown tape, and secured with coupler and tie wrap.It happened during patient use but with no information regarding outcome.
Additional Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3, h6, and h10 device evaluation: according to the investigation and per samples sent by the customer we cannot determine a root cause since the id for tubing part number 29212-006 was dimensioned according to pqas.57-1024 etal and no issues were found, also the od for component part number mx65-4223a was dimensioned according to rmqas 3128a etal and no issues were found.Additionally the ifu part number 33571-001 included in the fg 29028-003 has the following note: "ensure all connections and fittings are hand tightened before use".Therefore, the root cause was undetermined.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850S
• 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, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12833147
• Report Number: 8030673-2021-00217
• Device Sequence Number: 4780281
• Product Code: LSZ
• UDI-Device Identifier: 50190752159745
• UDI-Public: (01)50190752159745(11)20210320(10)0004160559
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: BOXED PATIENT CIRCUIT ASSY, 3100A, 850SL
• Device Catalogue Number: 29028-003
• Device Lot Number: 0004160559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2021
• 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