MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cough (4457)

Event Date 04/01/2021

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation from a user of a dreamstation2adv auto cpap who coughs every time he uses his device.The user was prescribed two different inhalers by his physician.User states he does not cough when using his resmed device.The unit was replaced for the user.The device has been returned to the manufacturer but has not yet been investigated.The investigation is on-going.A final report will be filed once the investigation is completed.

Manufacturer Narrative

The manufacturer previously reported type of reportable event as other in section h1.After review, it was determined type of reportable event should have been serious injury.

Manufacturer Narrative

The manufacturer previously reported an allegation from a user of a dreamstation2adv auto cpap who coughs every time he uses his device.The user was prescribed two different inhalers by his physician.User states he does not cough when using his resmed device.The unit was replaced for the user.The device was returned to the manufacturer for investigation.The external examination showed there was no evidence of contamination on the outside of the device.The device was hooked up to known good power cord and supply and the device operated correctly.The error log showed there was one instance of a e-41 reboot error.The internal investigation revealed contamination in the water tank.There was also unknown contaminate on the therapy start button.The manufacturer was unable to address the complaint or symptoms.The device operated as per specifications.

• Brand Name: DREAMSTATION2ADV 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 15208 ; 4125423300
• MDR Report Key: 17136139
• MDR Text Key: 317245295
• Report Number: 2518422-2023-13582
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male