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

Model Number	INX3100S19
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred and the patient dying while on the device.A lab investigation was performed and stated, "pil visually inspected the bi-pap a40 pro and did not observe any visual defects.In addition, the tech verified that the unit was operating on sw version 1.1.2.0 at the time of the event.During the pil review of the log the pil verified multiple e96's had occurred with an incorrect date of (b)(6) 1970, occurring before an sd card insert on (b)(6) 2022.The pil could also confirm a ventilator inoperative showing a date of (b)(6) 2022 02:11 am in the alarm log of the display in the unit alarm log.However, the vent inop does not show in the log.Tech verified that the unit operates at the pil without issue or error code during unit operation at the pil.Due to the unit multiple e96's noted in the log and the vent inop noted in the alarm log of the unit, the pil tech reached out to engineering.Engineering has added a interleaved log to show the log entries that are corrupt.Per engineering , this is a software issue, falling under existing investigations.Extensive investigations have turned up evidence of serial flash writes failing/hanging, possibly associated with multiple sleep events getting queued up without being processed so that there's a queue overflow or deadlock.Per engineering this has been verified as a software issue and is being further evaluated by engineering.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18764583
• Report Number: 2518422-2024-09335
• Device Sequence Number: 11887184
• Product Code: MNT
• UDI-Device Identifier: 00606959055025
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Device Model Number: INX3100S19
• Device Catalogue Number: INX3100S19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: Death
• Patient Sex: Unknown