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

Model Number	INX3100S19
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Decrease in Pressure (1490); Environmental Compatibility Problem (2929); No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bipap a40 pro red alarm condition occurred.The reporter states the device dashboard turned red and stopped providing air to the patient.The family member restarted the device.The patient had drowning for a few minutes.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The bipap a40 pro model number inx3100s19 is substantially similar to the bipap a40 model number 1111177 and will be reported in the united states under bipap a40 pro, 501k number: k121623.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a bipap a40 pro red alarm condition occurred.The reporter states the device dashboard turned red and stopped providing air to the patient.The family member restarted the device.The patient had drowning for a few minutes.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.New information: the ventilator was returned to the manufacturer product investigation lab (pil) for evaluation and the customer¿s complaint was not duplicated.The event log was reviewed, and ventilator inoperative alarms were confirmed in the error log.The device failed a test step (pressure sensor).Upon further investigation the device etched disk was confirmed to be partially clogged with debris that appear to have originated from an external source.The device's etched disk needs to be replaced to address the issue.The original part was discarded.Additional information added to box h.

• 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: 19991759
• Report Number: 2518422-2024-51630
• Device Sequence Number: 7075462
• Product Code: MNT
• UDI-Device Identifier: 00606959055025
• UDI-Public: (01)00606959055025
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: INX3100S19
• Device Catalogue Number: INX3100S19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown