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

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

Device Problem Disconnection (1171)

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

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.The issue was with 3 circuits and two patients (it occurred repeatedly on one patient).Please see (b)(4).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 secure connections on the wet side of the 29028-003 boxed patient circuit assy, 3100a, 850s disconnected while a patient was attached and being ventilated.This caused loss of pressure and stopped delivery.End user manually ventilated the patient until the circuit was changed.The customer confirmed that there was no patient harm associated with the reported event.

• 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: 15141951
• MDR Text Key: 297035912
• Report Number: 8030673-2022-00263
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159745
• UDI-Public: (01)50190752159745(10)0004155820(11)20200810
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/04/2022

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
• Device Operator: Health Professional
• Device Model Number: BOXED PATIENT CIRCUIT ASSY, 3100A, 850S
• Device Catalogue Number: 29028-003
• Device Lot Number: 0004155820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2020
• 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