MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1116155
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap a30, silver series device was returned to a third-party service center for remediation.There was no injury or harm reported.The device was not reported to be in patient use.During the evaluation of the device, at a third-party service center the device was visually inspected and found no evidence of foam degradation.The customer complaint was not confirmed.Additionally, a critical error code e-47 and e-96 was noted to have occurred indicating the central processing unit cannot communicate with the pressure sensor using spi bus.Replacement of the device's system board was required to address the issue.The device passed all final testing.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with plexus.The device history record has been reviewed and approved by plexus quality assurance.

• Brand Name: BIPAP A30
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22939576
• Report Number: 2518422-2025-109580
• Device Sequence Number: 21298331
• Product Code: MNS
• UDI-Device Identifier: 00606959039384
• UDI-Public: (01)00606959039384
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 1116155
• Device Catalogue Number: 1116155
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2016
• 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