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

Model Number	CAX400H12
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A continuous positive airway pressure (cpap) device was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, an issue related to the device's sound abatement foam was observed.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.This action was reported to the fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: b3 date of event: previously reported as 06/09/2021 ; updated to (b)(6)2021 d8 was this device serviced by a third party?: previously reported as no ; updated to unknown e1 initial reporter contact (name) & address e4 initial reporter also sent report to fda?: previously reported as no ; updated to unknown g2 report source: previously reported as company representative ; updated to foreign/user facility.
Additional Manufacturer Narrative
A dreamstation cpap pro device was returned to the manufacturer for service.During the evaluation, evidence of foam degradation was found.Additionally, the blower was noisy and not working.The service center retrieved and reviewed the device's error logs.There were no errors found.No patient or user harm or injury has been reported.The manufacturer confirmed visible foam degradation in the device.The unit has been scrapped after device evaluation was completed.Section g1 is updated in this report.Section h6 is corrected in this report.The manufacturer's device evaluation was available at the time the previous reports were submitted.

• Brand Name: DREAMSTATION CPAP PRO W/HUMID
• 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 ; 7243512041
• MDR Report Key: 12129961
• Report Number: 2518422-2021-02098
• Device Sequence Number: 4700459
• Product Code: BZD
• UDI-Device Identifier: 00606959026568
• UDI-Public: 00606959026568
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2025

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: CAX400H12
• Device Catalogue Number: CAX400H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 06/09/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMIDIFIER SN (B)(6); HUMIDIFIER SN H20582333773E.
• Patient Sex: Unknown