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

Model Number	AUX1131S15
Medical Device Problem Codes	Degraded (1153); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted regarding a dreamstation bipap avaps30ae aam, au device.On the rwo, the complaint reports black foam, in addition to other operating issues.There was no reports of serious injury or harm, and neither was there any mention of medical intervention.
Additional Manufacturer Narrative
The replacement dreamstation unit provided to the customer contained a blower box with the silicone foam.In (b)(6) 2024, the biomedical engineering unit at (b)(6) conducted servicing on this device and replaced the blower box containing silicone foam with a blower box containing the pe-pur foam.Post service, the device failed power cycle test and was returned to philips for evaluation.Upon evaluation of the device, the manufacturer's bench engineer removed the covers of the device and identified that the blower box assembly contained pe-pur foam.A complaint file was raised to the manufacturer for further investigation.The manufacturer confirmed with the customer that the affected device was not used on a patient and was sent to philips australia after servicing.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20129398
• Report Number: 2518422-2024-100252
• Device Sequence Number: 3226663
• Product Code: MNS
• UDI-Device Identifier: 00606959424913
• UDI-Public: (01)00606959424913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: Lay User/Patient
• Device Model Number: AUX1131S15
• Device Catalogue Number: AUX1131S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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