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

Model Number 3100 A

Device Problem Unintended Power Up (1162)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 3100a ventilator intermittently turning on and making a buzzing noise.As of this time, there is no information about patient involvement associated with this reported event.

Manufacturer Narrative

Results of investigation: vyaire field service went onsite.Found circuit would not pressurize, the column fan was very loud and the solenoid 1 is not activating when the "reset power fail" button is pressed.As a resolution the technician replaced the column fan and solenoid 1.Technician performed calibration of the unit.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: failure analysis conducted visual inspection of solenoid showed the wire receptacle missing as though it was cut off and not returned with the part.At the current state the reported issue may have been related to a loose connection with the missing receptacle.Visual inspection of fan assembly found that the fan have been heavily used and after physically spinning the fan blades found to have resistance indicating the internal bearings are damaged.The fan running intermittently verifying the reported issue.As this issue arose after a 6k pm (preventive maintenance) was needed no further actions are needed at this time.Physical damage of solenoid inhibited an investigation and improper maintenance was found as the contributing factor for the fan assembly.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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: 11416061
• MDR Text Key: 238669363
• Report Number: 2021710-2021-13452
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20100811
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

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: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 04/28/2021
• Supplement Dates FDA Received: 05/24/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1