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

Model Number	1116155
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no harm or injury reported.During evaluation, no foam particles were noted in the airpath, yet foam degradation was noted.Additionally, the patient¿s complaint was confirmed, and the device was corrected.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
This report is being sent to correct our previous submission.The device was returned and during evaluation the patient¿s complaint was confirmed, and the device was corrected.No malfunction or adverse event was reported from the field.No evidence of foam degradation or particulate matter was identified during evaluation.Based on the available information, this event does not meet the criteria for a reportable incident.

• Brand Name: BIPAP A30
• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24493568
• Report Number: 2518422-2026-105941
• Device Sequence Number: 5104798
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 1116155
• Device Catalogue Number: 1116155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2020
• 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
• 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