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

Model Number 3100 A

Device Problem Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been return for investigation.Therefore, no further evaluation can be identified.

Event Description

The customer reported that a 3100a ventilator will not pressurize.No patient involvement.The reported issue was detected prior to use.

Manufacturer Narrative

Result of investigation: : a vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr found that the adjust knob is loose.Realigned adjust knob and do minor adjustment on pr3.Performed pt cal and performance test, both passed per 3100a label.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, ca
• MDR Report Key: 10498341
• MDR Text Key: 205905267
• Report Number: 2021710-2020-12501
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• 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: 08/24/2020

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: 768901
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/06/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1