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

Model Number	CNX500T17
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have lung nodules.There is no report of the medical intervention that the patient has received at this time the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have lung nodules.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have lung nodules.There is no report of the medical intervention that the patient has received at this time.There was no report of serious patient harm or injury.Section b1 was corrected for product problem.(both adverse event and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects - impact code was corrected, type of investigation findings and investigation conclusions has been updated.The device was returned to manufacturer's service center for further evaluation.During the evaluation of the device at the manufacturer's service centre, the device was visually inspected and found no evidence of foam degradation.The manufacturer's service center concludes that they couldn't confirm the customer's allegation and there was no visibl foam degradation and unit passed the final test.

• 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: rosko melissa ; 1001 murry ridge line; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 12174106
• Report Number: 2518422-2021-02181
• Device Sequence Number: 1632005
• Product Code: BZD
• UDI-Device Identifier: 00606959042193
• UDI-Public: 00606959042193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CNX500T17
• Device Catalogue Number: CNX500T17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/04/2023
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/07/2021; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown