MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	GBX3100H19
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The device was returned to a third-party service center for evaluation.At this time, no information has been received on details of the investigation of the device, and a warranty replacement has been approved.A final report is being submitted.If any additional information is received, a supplemental report will be filed.Prior to identifying the issue described in fsn 2023-cc-src-039, complaints associated with the issue did not meet requirements for vigilance reporting as a reportable incident.As part of the hhe process, a retrospective review of complaints associated with the issue described in fsn 2023-cc-src-039 was necessary to reassess reportability.Upon this further assessment, these complaints are being reported.The bipap a40 pro (gbx3100h19) is substantially similar to the bipap a40 and will be reported in the united states under bipap a40, 510k number: k121623.

• Brand Name: BIPAP A40 PRO
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18711913
• Report Number: 2518422-2024-07609
• Device Sequence Number: 20880978
• Product Code: MNT
• UDI-Device Identifier: 00606959055087
• UDI-Public: 00606959055087
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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
• Operator of Device: Other
• Device Model Number: GBX3100H19
• Device Catalogue Number: GBX3100H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• 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