MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100 A

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be determined yet.

Event Description

The customer reported that the 3100 a has a burnt smell coming from the driver and the active driver overheat led.There is no patient involvement in this reported event.

Manufacturer Narrative

Results of investigation: the suspect device has been returned to the manufacturer for evaluation and the service technician was not able to confirm the reported issue.The unit passed all testing and calibration performed by the technician.The complete device set up was left to cycle for over 144 hours no smell or any abnormal performances issues or alarms being active on either of the assemblies returned.The device was hold for 90 days then it will be disposed.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9747181
• MDR Text Key: 180643456
• Report Number: 2021710-2020-11402
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003000
• UDI-Public: (01)10846446003000
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 3100 A
• Device Catalogue Number: 768910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1