MAUDE Adverse Event Report: RESPIRONICS, INC BIPAP A30; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BR1111143
Medical Device Problem Codes	Degraded (1153); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged to seeing white residue in the mask.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an issue related to a bipap device's sound abatement foam was alleged.The patient has alleged to seeing white residue in the mask.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.No foam particles or degradation was observed.The device's downloaded event log was reviewed.Ventilator inoperative alarm conditions were observed which are included in the voluntary field safety notice / recall notification related to a ventilator inoperative condition occurring in certain bipap, and mechanical ventilator devices.No repairs were performed as the device was scrapped.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.Sections d8, d9, g1, h2, h3, h6, h7 and h8 have been updated to reflect additional information.

• Brand Name: BIPAP A30
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 15043794
• Report Number: 2518422-2022-62520
• Device Sequence Number: 5060514
• Product Code: MNS
• UDI-Device Identifier: 00606959039445
• UDI-Public: 00606959039445
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: Lay User/Patient
• Device Model Number: BR1111143
• Device Catalogue Number: BR1111143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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: Unknown
• 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