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

Model Number DSX400H11C

Device Problem Degraded (1153)

Patient Problem Pulmonary Edema (2020)

Event Date 07/02/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop fluid in their lungs.The patient required removal of the fluid as a response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 an issue related to a cpap device's sound abatement foam.Patient has alleged to develop fluid in lungs.The patient required removal of the fluid as a response to the reported event.This event is assessed as not related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.The device was returned to the manufacturer's product investigation laboratory for investigation.Visual inspection confirmed positive deposit of foam particulate on the fit tool.Performance testing/verification of complaint confirmed the evidence of foam degradation associated to this allegation.Review of secondary findings showed the evidence of liquid ingress.Pil was able to confirm the complaint or address the symptoms specified.The device was hooked up to a known good power supply and power cord, airflow was verified to be operating correctly.The error log showed that there were no instance of errors on the device.Pil was able to confirm the presence of degraded sound abatement foam in the device.

• Brand Name: DREAMSTATION CPAP PRO W/HUM/CELL, DOM
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12371452
• MDR Text Key: 268270544
• Report Number: 2518422-2021-03208
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX400H11C
• Device Catalogue Number: DSX400H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other