MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	FRX521H14C
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a thermal malfunction of a dreamstation 2 device.The manufacturer received information alleging a spark at the pneumatic inlet port.Additionally, it was reported that smoke was observed and a burning smell.There was not reported harm or serious injury.No medical intervention was specified by the patient.During the evaluation of the device the home referral service visually inspected the device and found evidence of a damaged motherboard.
Additional Manufacturer Narrative
The manufacturer previously reported was contacted in reference to a thermal malfunction of a dreamstation 2 device.The manufacturer received information alleging a spark at the pneumatic inlet port.Additionally, it was reported that smoke was observed and a burning smell.There was not reported harm or serious injury.No medical intervention was specified by the patient.During the evaluation of the device the home referral service visually inspected the device and found evidence of a a damaged motherboard.After reviewing information from patient it is determined that the report should be as he manufacturer received information alleging an issue with a ds2 device.The customer reported the following: "the home referral service (hrs) was called in to replace the machine.Approximately 30 to 40 seconds after plugging in and switching on the machine, it suddenly shut down and the display disappeared.The hrs tried to change the mains plug, but without success.A further attempt at a different mains socket also failed: although the device remained plugged in, it still wouldn't restart.The hrs then disconnected the humidifier to check whether it could be the cause of the malfunction.Observing the pneumatic inlet port, he noticed a spark (small flame), which immediately led him to disconnect the unit.Slight smoke escaped, accompanied by a burning smell, suggesting potential damage to the electronic board.There was no immediate impact on the patient, but patient must be fitted with another machine.The product was not in use at the time of the event there was no patient harm or injury reported.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.On previously submitted report, describe event or problem in box b, evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid in box h was incorrect.Section describe event or problem in box b, evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid in box h has been updated/corrected in this report.

• Brand Name: DS2ADV AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 21852751
• Report Number: 2518422-2025-103976
• Device Sequence Number: 12913542
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2026

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: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 07/08/2026
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/22/2025; 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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