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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Fatigue (1849); Fever (1858); Headache (1880); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2021

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 sinus infection, cough, fever, pink bubbles on roof of mouth, nose congestion, headache, fatigue.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.

Manufacturer Narrative

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the soundabatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer reported an allegation of an issuerelated to a cpap device's sound abatement foam.The manufacturer received information alleged sinus infection, cough, fever, pink bubbles on roof of mouth, nose congestion, headache, fatigue.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.Secondary findings: 1 instance of e-193 err_usb_host_no_device logged (1117539 v20).Continue errors do not impact therapy, so this error will be considered irrelevant for the investigation.0 blower hours and 0 therapy hours were logged, suggesting the device data was reset prior to pil receipt.6243.4 machine hours were logged.Care orchestrator data was unavailable.Dark dust or dirt on and around the outlet port.Light grey film on the inside surface of the upper enclosure, inside surface of the front panel, bottom enclosure, and rear panel.Fine, white powder found on the sk isolators and the grommet risk tags (er 2219697 v20) associated with this failure mode include: irrit02, infect01.Section h6 updated in this report.

• 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: 15509067
• MDR Text Key: 305276932
• Report Number: 2518422-2022-84628
• 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: 06/22/2023

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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