MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100 A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 07/15/2020

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 returned for evaluation.Therefore, no root cause could be determined yet.

Event Description

The customer reported to vyaire medical that the 3100a frequency fluctuates between 10-15 back and forth.You can hear the unit slow down and speed up as well.At this time, there is no information about patient involvement on the reported event.

Manufacturer Narrative

H10: vyaire medical was able verify the reported issue.A visual inspection of the power module p# 768930 s/n ca001154 was performed and no visual damage was found.After installing the assembly into a known good top level unit and performing a successful operation verification test, reported issue cannot be reproduced (the frequency fluctuating or not reaching its specification of 15 +/- 0.3 hz).Frequency is 14.8 hz which is within specification.The system was then cycled for over 30 minutes and eventually the frequency began to fluctuate, and the driver can be heard changing in oscillation.The output of ic u1 was then monitored via test point tp2 and this matched the response of the frequency meter.This ic p# 462730 is responsible for the delivery of the proper frequency and has been isolated as the cause of the reported issue.Found out that the ic u1 p# 462730 is defective that is causing fluctuations in frequency.

• Brand Name: 3100A VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10397033
• MDR Text Key: 202581138
• Report Number: 2021710-2020-12329
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1