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

Model Number	CAX400S12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Scar Tissue (2060); Bronchial Hemorrhage (4456); Unspecified Respiratory Problem (4464)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused bleeding, scar tissue and lung issues.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 allegation of an issue related to sound abatement foam.The end user indicated ozone or other unapproved cleaning and disinfection method was used.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information wasreceived and section b5 should be reported as:the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the soundabatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused caused bleeding, scar tissue and lung issues while using this device.The reported events of bleeding, scar tissue and lung issues and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.Ifany additional information is received, a follow up report will be filed.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
Additional Manufacturer Narrative
Additional information was received on (b)(6)2024, and section h11 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused bleeding, scar tissue and lung issues.The sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected for adverse event and product problem.(only the product problem was checked in the previous mdr.) section b2 was corrected to other serious or important medical events.(previously, it was blank.) section h1 was changed from malfunction to serious injury.Section h6 health effects - impact code was corrected.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging that caused bleeding, scar tissue and lung issues that are related to cpap device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.The manufacturer performed the external and internal inspection observed dust-like contamination on the blower box.Dust-like contamination on the top of the blower motor.Evidence of sound abatement foam degradation/breakdown was observed.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found five error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was evidence of sound abatement foam degradation and there is no visible damage or functionality failures of the device.The manufacturer observed dust contamination in the device is consistent with being from an external source.In this report, section d8, d9, h2, h3 and h6 has been updated.

• Brand Name: DREAMSTATION CPAP PRO, CAN
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 12181714
• Report Number: 2518422-2021-02248
• Device Sequence Number: 936599
• Product Code: BZD
• UDI-Device Identifier: 00606959026551
• UDI-Public: 00606959026551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 12/22/2025

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: CAX400S12
• Device Catalogue Number: CAX400S12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/09/2023; 11/13/2024; 11/03/2025
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/14/2021; 04/26/2023; 11/28/2024; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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 Age: 61 YR
• Patient Sex: Female