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

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, vyaire technical support suggested customer to calibrate r17 which calibrates the panel meter.The customer reported that the panel meter is back to normal by adjusting r17.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 frequency of 3100a was drifting from 15 to 10.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: d10, g4, g7, h2, h3, h6 and h10.Result of investigation: the vyaire failure analysis laboratory received the unit.A visual inspection of driver assembly was performed and no visual sign of physical damage was found.The printed circuit board assembly was installed into a known good top level unit and measured test point tp8 and powered on.The frequency panel meter was showing 15hz and the oscilloscope is reading 14.7hz (reading good).Performed the 6k preventive maintenance and the unit passed.The unit was then left to cycle for 2 hours with no fluctuations in frequency readings.

• 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
• MDR Report Key: 10107158
• MDR Text Key: 193282912
• Report Number: 2021710-2020-12047
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20111201
• 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: 05/05/2020

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: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention