MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	GBX3100S19
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of ventilator inoperative is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.A field action was initiated with record id 2024/003/027/601/074 and consisted of a field safety notice fsn 2023-cc-src-039.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.The bipap a40 pro gbx3100s19 is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.Review of the dhr for this device, serial number (b)(6), did not find any non-conformances or abnormalities related to the [reportable] malfunction/allegation identified in this complaint record during testing of the device prior to distribution.
Event or Problem Description
A bipap a40 proefl ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.Device evaluation by the third-party service center indicated a ventilator inoperative device error code was present in the error log indicating failure of the outlet pressure sensor.The issue would require replacement of the device printed circuit board assembly to address the issue.However; no parts were replaced.The customer requested the device be scrapped.

• Brand Name: BIPAP A40
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• 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: 25657554
• Report Number: 2518422-2026-027599
• Device Sequence Number: 9837656
• Product Code: MNT
• UDI-Device Identifier: 00606959055063
• UDI-Public: (01)00606959055063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: GBX3100S19
• Device Catalogue Number: GBX3100S19
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2022
• 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
• Usage of Device: Reuse
• 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