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

Model Number 3100 A

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).The reported issue was also by rt dept while doing the patient circuit calibration.As a resolution, the customer will replaced the panel meter.The suspect/device component has not been returned to vyaire.Therefore, a definitive root cause cannot be determined.Any additional information received from the customer will be included in a follow-up report.

Event Description

It is reported to vyaire medical that 3100a ventilator experienced a fluctuating map between 53-58 cm on the display while checking the zero/span on this unit.The external meter is reading stable at 37 cm.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, HIGH FREQUENCY
• 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: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, il ; 3273284
• MDR Report Key: 10451808
• MDR Text Key: 204354566
• Report Number: 2021710-2020-12332
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003024
• UDI-Public: (01)10846446003024(11)20100203
• 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: 07/29/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2010
• 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