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 Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire field service representative (fsr) went onsite and evaluated the ventilator.The tp4 reading on power controller were 3.33 and -4.59 where it should be 3.5 and -3.95.Fsr installed new pot, driver power module and driver assembly.Calibrations were done and passed the test.Fsr run the unit for about 20 minutes on different power settings no errors found and pressure remained constant according to settings.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 a low delta p on 3100a while connected to a patient.At this time, there is no information regarding patient harm and remedial action taken by the healthcare facility 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: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10131369
• MDR Text Key: 194532822
• Report Number: 2021710-2020-12043
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20130501
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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