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

Model Number	1109591
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
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 is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Additional information was received regarding the calibration failure on the device.The device's main system board was replaced to address the issue.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 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 is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Additional information was received regarding the calibration failure on the device.The device's main system board was replaced to address the issue.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.The manufacturer's service technician replaced the device's main printed circuit assembly board to address the issue.After the part was replaced on the device, the manufacturer's service technician ran the device for two hours and it passed all tests on the device.

• 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: 20025551
• Report Number: 2518422-2024-100098
• Device Sequence Number: 18329992
• Product Code: MNS
• UDI-Device Identifier: 00606959042704
• UDI-Public: (01)00606959042704
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: Other
• Device Model Number: 1109591
• Device Catalogue Number: 1109591
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 05/29/2025
• 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
• 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