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

Model Number	1109590
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that during the evaluation of a bipap a30 device at a service center, it was discovered that there was a ventilator inoperative alarm in the device's error log.This issue has been identified under the fsn 2023-cc-src-039 due to interruptions and/or loss of therapy due to a ventilation inoperative alarm.There was no patient harm or serious injury reported with this notification.The device was not in patient use.During the evaluation of the device, the event log was reviewed and there was a ventilator inoperative error in the device's history.There was no cause noted by the service technician that contributed to the ventilator inoperative error.Additionally, the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.No repair was performed.The device was scrapped by the service center after the evaluation was completed.

• 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: 24676693
• Report Number: 2518422-2026-009962
• Device Sequence Number: 10071352
• Product Code: MNS
• UDI-Device Identifier: 00606959042698
• UDI-Public: (01)00606959042698
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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
• Operator of Device: Other
• Device Model Number: 1109590
• Device Catalogue Number: 1109590
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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
• 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