MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	EUX500S15
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a dreamstation auto cpap device's thermal event.The manufacturer received information alleging that the device smells burnt, humidifier no longer recognizes headset tube.Additionally, the device was returned to the third-party service center.During the evaluation, it was found that the pca was burnt.There was no serious patient harm or injury.At this time, no medical intervention has been reported, and no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The device was returned to the third-party service center for evaluation.During the evaluation of the device at the service center, inspection of the pca board revealed evidence of thermal damage; however, no other device failures potentially related to the thermal damage were observed.Based on the available information, the root cause of the issue could not be conclusively determined.The pca board needs to be replaced.Additionally, during the evaluation contamination was observed in the blower, and the pollen filter was noted to need replacement.The device's pca board, blower assembly, and pollen filter were replaced, the device was inspected and passed final testing.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 21114110
• Report Number: 2518422-2025-001309
• Device Sequence Number: 8682947
• Product Code: BZD
• UDI-Device Identifier: 00606959027435
• UDI-Public: (01)00606959027435
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: Lay User/Patient
• Device Model Number: EUX500S15
• Device Catalogue Number: EUX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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