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 Information (3190)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire that the 3100 a experienced fluctuations with mean airway pressure (map) and amplitude settings.At this time, it is unknown if there was any patient involvement associated with the reported issue.Tests/lab data, including dates.

Manufacturer Narrative

Vyaire complaint #: (b)(4).Device evaluation: g6, h2, h3, h6, h10 results of investigation: a vyaire medical service representative (fsr) evaluated the device onsite and verified the reported problem.Fsr found fluid in the bias flow line.The fluid was removed, and the device ran normally.Device passed performance testing.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; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9526700
• MDR Text Key: 189477806
• Report Number: 2021710-2019-11205
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20150422
• 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: 02/25/2021

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?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1