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

Model Number DSX400H11C

Device Problems Degraded (1153); Device Contamination with Chemical or Other Material (2944)

Patient Problems Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

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 patient alleges sinus infections every 3 months with nasal and throat irritation.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.A device was returned to the manufacturer service center 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 device was visually inspected during the evaluation, and unknown dust/dirt contamination was present on all unit surfaces.The manufacturer observed an unknown white dust residue present on the side panel o-ring, blower box housing, and motor casing/impeller.Unknown dust/dirt contamination is present throughout the base unit.A keratin-like substance was observed around the blower box outlet.The manufacturer confirmed the presence of degraded sound abatement foam using a fitt.A keratin-like substance was observed around the blower box outlet.The manufacturer is unable to address the symptoms outlined in the complaint directly.The manufacturer can confirm that there was evidence of sound abatement foam degradation/breakdown observed in the base unit.The manufacturer can confirm the presence of contamination in the airpath.

• Brand Name: DREAMSTATION CPAP PRO
• 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 15208 ; 4125423300
• MDR Report Key: 17686374
• MDR Text Key: 322722709
• Report Number: 2518422-2023-21724
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 06/12/2023
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1