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

Model Number DEX400S13

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Chest Pain (1776); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Headache (1880); Pain (1994); Irritability (2421); Eye Pain (4467)

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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing thoracic pressure, dyspnea, respiratory irritation and dry cough, headaches, fatigue, pain in the right side of the face and eye and mental/emotional changes.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was previously 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 an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing thoracic pressure, dyspnea, respiratory irritation and dry cough, headaches, fatigue, pain in the right side of the face and eye and mental/emotional changes.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of the device was completed by the manufacturer and found evidence of minor dust/cosmetic contamination on exterior of device and small amount of fine particulate on the blower.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.The device's event log was reviewed by the manufacturer and found no errors logged.The device was applied power and the device operated properly.The manufacturer concludes the contaminates found were consistent with dust, cosmetics and fine particulate, contamination inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.

• 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 15206 ; 2673970028
• MDR Report Key: 15796820
• MDR Text Key: 305377045
• Report Number: 2518422-2022-94149
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEX400S13
• Device Catalogue Number: DEX400S13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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