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

Model Number	ESX3100S19
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bipap a40 pro, model# esx3100s19 is substantially similar to the bipap a40, model# 1111169 and will be reported in the united states under bipap a40 pro, 501k number: 121623.
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The bipap a40 pro was returned to the manufacturer for evaluation and the customer¿s complaint was not duplicated.Error code e-96 was noted in the error log which engineering assumed to be related to a software issue.It was also confirmed that error code e-45 occurred while there was an issue writing to serial flash.Per engineering, via observation of the sd card contents that several months' worth of compliance data is missing as well.No ventilator inoperative was noted in the error/event log but was noted in the alarm log.It was confirmed that the device worked at the pil with no error codes or issues.Per engineering this event has been verified as a software issue and the extensive investigation has turned up evidence of a serial flash writes failing/hanging.This software issue is being further investigated and the unit is scrapped and being held for further evaluated.Currently a risk is being assessed and a capa is currently underway.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18343399
• Report Number: 2518422-2023-36123
• Device Sequence Number: 8489110
• Product Code: MNT
• UDI-Device Identifier: 00606959059368
• UDI-Public: 00606959059368
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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

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: ESX3100S19
• Device Catalogue Number: ESX3100S19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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