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

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).The technical support instructed the customer to do the driver controller frequency calibrations and see if it will solve the problem.After calibration, the customer reported that he is still having issues with the frequency.The technical support instructed the customer to swap the frequency panel meter and check if it will work.The customer called back and stated that the problem was solved after replacing the frequency panel meter.

Event Description

The customer reported that 3100a ventilator having issues with the frequency coming into specs.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10273905
• MDR Text Key: 198878797
• Report Number: 2021710-2020-12196
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446005394
• UDI-Public: (01)10846446005394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1