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

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

Device Problem Connection Problem (2900)

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

Event Date 12/26/2020

Event Type  malfunction  

Manufacturer Narrative

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 Description

The customer reported to vyaire medical that the boxed patient circuit assay, 3100a, 850l got disconnected from inspiratory limb going to the humidifier chamber.The issue occurred during patient-use and the device was reconnected.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: result of investigation: the customer sent a picture of the circuit recently opened.It was seen that there's disconnection between the tubing and the connector.However, the defect cannot be confirmed, since the picture shows a recently opened circuit and the customer mentions that the disconnection occurred during ventilation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Result of investigation: a picture and a decontaminated sample received.According to the investigation, it was observed that the tubing was disconnected from the component.Evaluation done according to the internal procedures looking for any dimensional defect and no issues found.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11308634
• MDR Text Key: 247024982
• Report Number: 8030673-2021-00149
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 020846446064121
• UDI-Public: (01)020846446064121(10)0004160560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

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
• Device Operator: Health Professional
• Device Model Number: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Device Catalogue Number: 29028-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 03/25/2021
• Supplement Dates FDA Received: 03/09/2021; 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1