MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30; PORTABLE ELECTRIC VENTILATOR

Model Number	1111149
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The capa process identified complaints not being created for quality issues found during third party servicing.Based on a review of records impacted by the identified issue, it was determined that this record needed to be corrected and is now being submitted accordingly.
Event or Problem Description
A bipap a30 was returned to a third-party service center for service.There was no serious patient harm or injury reported.There was no evidence the device was clinical 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 however, ventilator inoperative error code indicating a failure of the outlet pressure sensor was observed in the device's downloaded event log.The device's main board was replaced to address the issue.No final testing was documented.A final report is being submitted.If new information becomes available that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: BIPAP A30
• Common Device Name: PORTABLE ELECTRIC VENTILATOR
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24729908
• Report Number: 2518422-2026-111686
• Device Sequence Number: 9214531
• Product Code: MNT
• UDI-Device Identifier: 00606959039353
• UDI-Public: (01)00606959039353
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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
• Device Model Number: 1111149
• Device Catalogue Number: 1111149
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2015
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1814-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown