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

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical complaint number: (b)(4).At this time, vyaire medical has not received the suspect device for evaluation.Once evaluated, a follow-up medwatch report will be submitted.

Event Description

It was reported to vyaire medical that the ventilator is not provided the expected amplitude.There was no report of any patient involvement associated with this reported event.

Manufacturer Narrative

Vyaire complaint #: (b)(4).Results of investigation: a vyaire medical field service representative (fsr) evaluated the suspect device onsite.The fsr calibrated the pr2 and pr6 regulators as well as the printed circuit board (pcb).The operation of the device was confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9461647
• MDR Text Key: 184806764
• Report Number: 2021710-2019-11147
• Device Sequence Number: 1
• Product Code: LSZ
• 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: 02/24/2021

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: 11/14/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1