MAUDE Adverse Event Report: RESPIRONICS, INC. A30, FLOW GEN, BRAZIL; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1109590
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the discovery of ventilator inoperative error codes during evaluation.This issue has been identified under the fsn 2023-cc-src-039 due to interruptions and/or loss of therapy due to a ventilation inoperative alarm.There was no patient harm or serious injury reported with this notification.The device was not in patient use.During evaluation at the manufacturer's service center the a30, flow gen, brazil device was visually inspected and found no evidence of foam degradation, however a ventilator inoperative error code was confirmed in the event log.There is no documentation of what component is necessary to be replaced to address the issue.No repair was performed.Scrapping device due to replacement.

• Brand Name: A30, FLOW GEN, BRAZIL
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23897003
• Report Number: 2518422-2025-113261
• Device Sequence Number: 17475552
• Product Code: MNS
• UDI-Device Identifier: 00606959042698
• UDI-Public: (01)00606959042698
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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 Model Number: 1109590
• Device Catalogue Number: 1109590
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown