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

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical complaint number: (b)(4).A vyaire field service representative (fsr) went onsite and evaluated the ventilator.It was found that the pr3 regulator was turned all the way down which is causing this problem.Calibration was then performed to meet manufacturers specifications.Issue was resolved.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the 3100a ventilator would not stay on.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: 3100A VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda, ca
• 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: 10221562
• MDR Text Key: 197311089
• Report Number: 2021710-2020-12176
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446005394
• UDI-Public: (01)10846446005394(11)20100826
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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: 06/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1