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

Model Number	GBX3100H19
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bipap a40 pro ventilator inoperative condition occurred.There was no harm or injury reported.The customer stated, the machine turned itself off and then back on again around 3am.There was no alarm prior to turning off but the device beeped when it restarted.The device also alerted machine/ventilator inoperative.The customer restarted the device 10 to 15 minutes later and the issue repeated so the patient did not use the device overnight.The customer states the logs appeared to be corrupted around the time of the event.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 bipap a40 pro ventilator inoperative condition occurred.There was no harm or injury reported.The customer stated, the machine turned itself off and then back on again around 3am.There was no alarm prior to turning off but the device beeped when it restarted.The device also alerted machine/ventilator inoperative.The customer restarted the device 10 to 15 minutes later and the issue repeated so the patient did not use the device overnight.The customer states the logs appeared to be corrupted around the time of the event.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: 18711485
• Report Number: 2518422-2024-07597
• Device Sequence Number: 15217784
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• 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: Lay User/Patient
• Device Model Number: GBX3100H19
• Device Catalogue Number: GBX3100H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• 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: 10/12/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown