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

Model Number 3100B

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report a vyaire field service representative (fsr) went onsite and evaluated the ventilator.It was seen that driver for 3 ohms with a dvm is open.Order 3 ohms driver prq-(b)(4).No root cause has been determined at this time, since the investigation is still ongoing.

Event Description

It was reported to vyaire medical that the 3100b ventilator does not oscillate.At this time, there is no information regarding patient involvement associated with the reported event.

Manufacturer Narrative

Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation and it did not show any physical damage.The pcba was installed into a known good 3100b top-level unit and powered on then after a successful circuit calibration the system was cycled for over 1 hour and no functional issues were reproduced.Using oscilloscope id# (b)(6) (cal due 04may22) and no fluctuations of output from u7 pins #1, #2 were found.The reported issue was not duplicated.

• 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: 10820279
• MDR Text Key: 217163070
• Report Number: 2021710-2020-12829
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543(11)20081208
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1