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

Model Number DSX500H11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Memory Loss/Impairment (1958); Blurred Vision (2137); Dizziness (2194); Cough (4457); Insufficient Information (4580)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging dizziness, headache, memory loss, lack of focus, double vision, shortness of breath, and coughing 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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section h6 updated in this report.

Manufacturer Narrative

The manufacturer previously received information alleging dizziness, headache, memory loss, lack of focus, double vision, shortness of breath, and coughing 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's product investigation laboratory for investigation.An internal visual inspection of device was completed by the manufacturer and found evidence of minor stains and dust contamination on exterior of device, interior of device and on the seals of the humidifier and dry box.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminates found were consistent with minor stains and dust contamination on exterior of device, interior of device and on the seals of the humidifier and dry box.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Section d9, g3, h6 has been updated/corrected.

Manufacturer Narrative

Section h10 had incorrect information about device evaluation.It should have been reported as below.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.The manufacturer found minor stains and dust contamination on exterior of device, interior of device and its seals of the humidifier and dry box.The device's downloaded event log was reviewed by the manufacturer and found no erros logged.The device was hooked up to power supply, airflow was verified and the device operated properly.Pil confirms the presence of contamination in the airpath.Pil is unable to find evidence of sound abatement foam degradation or breakdown.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 13581521
• MDR Text Key: 296414047
• Report Number: 2518422-2022-06973
• 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,Followup,Followup
• Report Date: 09/11/2023

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: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 02/20/2023; 02/20/2023; 02/20/2023
• Supplement Dates FDA Received: 02/27/2023; 03/28/2023; 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2020
• 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