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

Model Number 3100A

Device Problem Mechanical Problem (1384)

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

Event Date 09/21/2020

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 was received.

Event Description

The customer reported that the positive end-expiratory pressure (peep) cannot adjust below 7cmh2o on 3100a ventilator.At this time, patient involvement associated with the event is unknown.

Manufacturer Narrative

Result of investigation: a field service representative went on site and the unit was found to be functioning as intended.It was determined that the issue was related to the caps and settings used.The ventilator cannot be set to a pressure below 10 cmh2o with a bias flow of 20 and a delta p of 30.To get pressure below 10 cmh20, the bias flow will need to be reduced.The customer has been referred to the operations manual showing setting examples.

• 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: 10686857
• MDR Text Key: 211676069
• Report Number: 2021710-2020-12700
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003000
• UDI-Public: (01)10846446003000(11)20071101
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 3100A
• Device Catalogue Number: 768910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1