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

Model Number	INX3100S19
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging a ventilator sometimes turns off and start again.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a ventilator sometimes turns off and start again.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.On the previously submitted report in box e country was reported as chile which was incorrect.Now updated to switzerland which is the correct country.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a ventilator sometimes turns off and start again.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.On the previously submitted report in box e country was reported as chile which was incorrect.Now updated to switzerland which is the correct country.The device was returned to the philips investigation lab (pil) for evaluation and the pil visually inspected the bipap a40 pro, intl and did not observe any visual defects.The device o2 sensor reading at ambient conditions was recorded to be 22.0.S.The error log was reviewed, and discovered errors related to err low priority thread locked and err software reset system initialization.After recording device settings, the unit was run with the bacteria filter on the outlet on an asl.No unexpected errors occurred.Visual inspection of the bacteria filters afterward did not show any debris.The error log was examined more thoroughly and noted the thread lock failures and system re-initialization alarms coincided.This complaint with these circumstances has been investigated, this unit has been scrapped per work instruction.

• Brand Name: BIPAP A40 PRO
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• 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: 18336008
• Report Number: 2518422-2023-35855
• Device Sequence Number: 20511393
• Product Code: MNT
• UDI-Device Identifier: 00606959055025
• UDI-Public: (01)00606959055025
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2022; 08/02/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/21/2023; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2020
• 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
• Patient Sex: Unknown