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

Model Number 3100B

Device Problem Melted (1385)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has 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 that the 3100b ventilator stopped while on a patient.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: a vyaire field service representative (fsr) went onsite and evaluated the ventilator.It was seen that it was seen that the ventilator won't pressurize, upper cooling fan not rotating, displays are off or erratic operation and measured power supply voltages missing.Fsr replaced power supply but it did not resolve issue.Noticed that when the alarm board was disconnected the voltages were back.Fsr replaced the alarm board and the ventilator run as intended.Performed the 7 year preventive maintenance that was due, replaced power driver module, checked power supply, calibrated pressure transducer and ddi board, checked out alarm function and pneumatics, calibrated driver controller and run final test.All tested ok according to factory specifications.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: 11148204
• MDR Text Key: 226071812
• Report Number: 2021710-2020-13066
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543(11)20100303
• 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
• Report Date: 12/14/2020

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: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1