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 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.The customer reported that they checked the pressure sense line with no water or residual inside.They also disconnected and checked the p3 related to the frequency potentiometer as well as the regulators on the plc.For now, they have reached the maximum frequency desired but they will be monitoring this case.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

The customer reported that the 3100 a unit's map fluctuates 2 cm with a maximum frequency of 8.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; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 10177097
• MDR Text Key: 196212971
• Report Number: 2021710-2020-12130
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003055
• UDI-Public: (01)10846446003055(11)20040629
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2020
• 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: 766522
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2020
• 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