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

Model Number	AUX3100S19
Medical Device Problem Codes	Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a device gave auditory tone and then stopped while in use.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 bipap a40 pro, model# aux3100s19 is substantially similar to the bipap a40, model# 1111169 and will be reported in the united states under bipap a40 pro, 501k number: 121623.H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
Previously report: the manufacturer received information alleging a device gave auditory tone and then stopped while in use.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.New information: the device evaluation is still pending but the following high priority alarm error codes were noted in the device event log: 39 (low min vent), 42 (apnea), 43 (circuit disconnect) only if there is a failure and 67 (soft power loss).The manufacturer's investigation is ongoing.A final report is being submitted at this time.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
Previously report: the manufacturer received information alleging a device gave auditory tone and then stopped while in use.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.The device evaluation is still pending but the following high priority alarm error codes were noted in the device event log: 39 (low min vent), 42 (apnea), 43 (circuit disconnect) only if there is a failure and 67 (soft power loss).The manufacturer's investigation is ongoing.A final report is being submitted at this time.If any additional information is received, a follow up report will be filed.New information: the ventilator was returned to the philips investigation lab (pil) for evaluation and the customer¿s complaint was not confirmed.The device was visually inspected and there was nothing to note.The device error logs were reviewed and noted on (b)(6) 2023 the unit went into sleep mode and the device was not powered up until (b)(6) 2023.At the time of entering sleep mode the detachable battery was the power source and the capacity is recorded as 97%.The unit seems not to be in use on the reported incident date.The unit performed as expected at the investigation lab.The device was scrapped.

• 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: 18243464
• Report Number: 2518422-2023-32755
• Device Sequence Number: 6571859
• Product Code: MNT
• UDI-Device Identifier: 00606959059177
• UDI-Public: 00606959059177
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup

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: AUX3100S19
• Device Catalogue Number: AUX3100S19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 05/23/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/29/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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