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

Model Number	CAX1130T12
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bipap a30 was alarming for a ventilator inoperative alarm condition.There was no harm or injury reported.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a bipap a30 was alarming for a ventilator inoperative alarm condition.There was no harm or injury reported.The device was evaluated by a third-party service center, and the customer's complaint was not duplicated.There were no ventilator inoperative error codes in the downloaded event log.The device was tested and passed all testing.

• Brand Name: DREAMSTATION
• 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: 21060206
• Report Number: 2518422-2025-00038
• Device Sequence Number: 18176790
• 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,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/26/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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-1812-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown