MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30 AAM H/HT, CA; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	CAX1130T12
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for service.The device was not in patient use.During the evaluation of the device at the third-party service center, visible foam degradation was found.No repairs were performed; the device was dispositioned to be scrapped.Additionally, error codes were found when the error log was checked.This device is not a life-sustaining device.No repairs were performed; the device was dispositioned to be scrapped.

• Brand Name: DREAMSTATION BIPAP AVAPS30 AAM H/HT, CA
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22126297
• Report Number: 2518422-2025-106282
• Device Sequence Number: 8841590
• Product Code: MNS
• UDI-Device Identifier: 00606959425521
• UDI-Public: (01)00606959425521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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
• Device Model Number: CAX1130T12
• Device Catalogue Number: CAX1130T12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2017
• 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: Reuse
• 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