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

Model Number	1076564
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device was evaluated 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 is no allegation of serious or permanent harm or injury.The device is not reported to be in patient use.During the evaluation the device was visually inspected and found evidence of "sound absorbing foam are deteriorated" which was documented in the evaluation.The device's inlet foam was replaced to address the issue.Additionally, not related to the recall, the device's main board w/ lcd, right side panel, and valve assembly have been replaced to address damage that was discovered during the evaluation of the device.

• Brand Name: BIPAP A30, INTERNATIONAL
• 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: 21314941
• Report Number: 2518422-2025-101760
• Device Sequence Number: 15665706
• Product Code: MNS
• UDI-Device Identifier: 00606959039308
• UDI-Public: (01)00606959039308
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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: 1076564
• Device Catalogue Number: 1076564
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2014
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown