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

Model Number	1109596
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Unspecified Respiratory Problem (4464); Nodule (4551)
Date of Event	01/01/2012
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from the patient alleging they cannot sleep as the bipap a40, flow gen, international device is alarming.The patient stated that they had two (2) lumps taken out on their left lung as their lung collapsed.A philips clinical expert assessed this as a serious injury and there was no indication that the device caused or contributed to the serious injury.The clinical expert stated the allegation of the patient stating the removal of two lumps on the left lung and lung collapsed are assessed as not related to the device in this case.Based on information available at this time, the device did not cause or contribute to a serious injury or death.The mentioned harm unable to sleep due to device alarming is assessed as a non-serious injury.Listed as the reason for using the device is sleep apnea.Philips is currently investigating this complaint; however, the device examination has not begun because the device has not yet been returned to the manufacturer for investigation.As part of the complaint handling process, the manufacturer will attempt to retrieve the device for investigation.The manufacturer's investigation is ongoing.If any additional information is received, a follow-up report will be filed.

• 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: 24643078
• Report Number: 2518422-2026-009793
• Device Sequence Number: 9786174
• Product Code: MNT
• UDI-Device Identifier: 00606959042742
• UDI-Public: (01)00606959042742
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1109596
• Device Catalogue Number: 1109596
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Unknown