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

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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

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.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 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.

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
• 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, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12833147
• MDR Text Key: 283485453
• Report Number: 8030673-2021-00217
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159745
• UDI-Public: (01)50190752159745(11)20210320(10)0004160559
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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, 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
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2021
• 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