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

Model Number DSX400T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dry Eye(s) (1814); Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Respiratory Insufficiency (4462)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging particles in tubing/chamber, nasal/throat irritation or soreness, difficulty breathing and shortness of breath, headaches, lightheaded, dizzy, nausea, dry eyes related to a cpap device's sound abatement foam.There was no allegation of serious or permanent harm or injury.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 particles in tubing/chamber, nasal/throat irritation or soreness, difficulty breathing and shortness of breath, headaches, lightheaded, dizzy, nausea, dry eyes related to a cpap device's sound abatement foam.There was no allegation of serious or permanent harm or injury.The device was returned to the manufacturer product investigation lab for further evaluation.The external and internal aspect of the device was inspected and the manufacturer observed dust/dirt contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, control dial, keypad, blower, blower box, blower outlet seal, rear panel o-ring, p4 power connector.Missing accessory module flip door.The manufacturer also found no odor coming from the device.Unknown contamination was observed inside the ui and rear panels.Liquid ingress was observed on the blower and blower box.A contaminate consistent with keratin was observed on the blower box.The manufacturer observed six continue error of e-53, three reboot error of e-130 and one stop error for e-200.Pca needs to replaced for these errors.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer confirmed no presence of degraded sound abatement foam.The manuafcturer concluded dust/dirt contamination in the airpath, likely from a source external to the device.Section h6 medical device problem code, type of investigation, investigation findings, investigation conclusions have been updated in this report.

• Brand Name: DREAMSTATION CPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13543842
• MDR Text Key: 285703677
• Report Number: 2518422-2022-04834
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX400T11C
• Device Catalogue Number: DSX400T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• 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