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

Model Number	1116155
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center, a "ventilator inoperative" code was found in the ventilator's downloaded error log.The device's board needs to be replaced to address the issue.Upon further review, this complaint has been deemed as a reportable event.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 20304871
• Report Number: 2518422-2024-59644
• Device Sequence Number: 7726161
• 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
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 09/22/2023
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2014
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown