MAUDE Adverse Event Report: RESPIRONICS, INC. DS2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX520H15C
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A dreamstation 2 cpap device was returned to a third-party service center in reference to a complaint of not turning on.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the pca had thermal damage.There was no allegation of patient or user harm/injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacture was previously reported that a dreamstation 2 cpap device was returned to a third-party service center in reference to a complaint of not turning on.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the pca had thermal damage.There was no allegation of patient or user harm/injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.During the initial investigation of the ds2 adv auto cpap device at the third-party service center, the device was visually inspected and found pca is burnt and corroded, as well as a corroded ui bezel ribbon cable.Contamination was observed on the heater plate, blower, blower outlet seal, and blower box.Additionally, the pollen filter required replacement as part of preventive maintenance activities.The device was returned to the manufacturer product investigation laboratory (pil) for further evaluation.Pil used a known good pil-supplied power supply and ac power cord with the ds2 (dreamstation 2) and observed no-power condition.Pil performed external and internal inspections of the device and observed that the iso (international organization for standardization) port contained white dust-like contamination, the iso (international organization for standardization) port had potential mineral deposits inside indicating possible water ingress, heater plate had dust-like contamination.Inlet/outlet seal missing.Pil also found possible thermal events across the back of the pca (printed circuit assembly) at q4.Reference capas 1299367 & 3376332 potential mineral deposits on top of pca (printed circuit assembly) indicate possible water was on the pca.Potential corrosion on top of the pca indicates possible water was on the pca.Ui (user interface) panel discolored underneath from potential thermal event.Additionally, dust-like contamination was observed on the blower motor, at the air inlet of the blower box, within the blower box, in the bottom enclosure, and on the heater plate spring as well as the bottom enclosure beneath the heater plate spring.Potential mineral deposits were also noted on and inside the blower motor, inside the blower box, within the bottom enclosure, and underneath the heater plate.The water tank was missing at the time of evaluation.Based on the observations, the source of the contamination was most likely external to the device.Finally, pil was able to confirm the complaint of smell of burning.No power and smell issue possibly due to the thermal event and potential corrosion on the pca.Section event date in box b; product brand name, product udi, device serviced by 3rdp and device avail.For eval in box d; device eval.By mfg? in box g, (device) problem code grid, health impact grid, evaluation method code grid, evaluation results code grid, component code grid and conclusion code grid in box h has been updated/corrected in this report.The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device serial number (b)(6), review confirms that the device met the final acceptance criteria and was released for final distribution.
Additional Manufacturer Narrative
The manufacture was previously reported that a dreamstation 2 cpap device was returned to a third-party service center in reference to a complaint of not turning on.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the pca had thermal damage.There was no allegation of patient or user harm/injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.During the initial investigation of the ds2 adv auto cpap device at the third-party service center, the device was visually inspected and found pca is burnt and corroded, as well as a corroded ui bezel ribbon cable.Contamination was observed on the heater plate, blower, blower outlet seal, and blower box.Additionally, the pollen filter required replacement as part of preventive maintenance activities.The device was returned to the manufacturer product investigation laboratory (pil) for further evaluation.During functional testing, using a known-good philips-supplied power supply and ac power cord, it was confirmed that the device exhibited no power.Evidence of possible thermal events across the back of the pca (printed circuit assembly) at q4.Potential mineral and corrosion on the top of the pca indicates possible water was on the pca.Additional findings included ui (user interface) panel discolored underneath from potential thermal event.Pil concluded that the complaint of the device not turning on was confirmed.The observed no-power condition was possibly caused by a thermal event and corrosion on the pca.External and internal inspection identified white dust-like contamination within the iso (international organization for standardization) port, heater plate, air inlet of the blower box, blower box, bottom enclosure, heater plate spring and bottom enclosure under the heater plate spring.Potential mineral deposits were observed within the iso (international organization for standardization) port, inside blower motor, inside blower box, inside bottom enclosure, underneath heater plate.The water tank was missing and inlet/outlet seal missing at the time of evaluation.Based on the observations, the source of the contamination was most likely external to the device.The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device serial number (b)(6), review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: DS2 ADV 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: 21689859
• Report Number: 2518422-2025-103381
• Device Sequence Number: 18496691
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: (01)00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2026

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: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 06/30/2026; 07/16/2026
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/09/2026; 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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