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

Model Number 3100 A

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported to vyaire medical that audible internal leak occurred on the 3100 a device.The customer reported there was no patient involvement associated with the reported event.

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H10: a vyaire field service representative(fsr) evaluated the device onsite and removed the top cover to look for any leaking parts.Nothing found at that time.2k pm was performed on the unit to ensure that the unit was working properly.After a few corrections on the unit it is ready for patient usage.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

H11: after further review of this complaint.Vyaire medical found out that this complaint is a duplicate of (b)(4).An original mdr for this reported issue was submitted under mfr report # 2021710-2024-18802.Please disregard and void mfr report #2021710-2024-18941.

• 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 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18996192
• MDR Text Key: 338895081
• Report Number: 2021710-2024-18941
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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