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

Model Number DSX500T11C

Device Problems Fire (1245); Smoking (1585)

Patient Problems Dyspnea (1816); Headache (1880)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of allegations of a thermal event to his dreamstation auto cpap.The user alleges the machine started smoking where the power supply plugs into the device.The user unplugged the (b)(6) power supply and a small flame came out of the power input.The flame was extinguished.The user reports shortness of breath, headaches, very tired and has a hard time waking up in the morning.No medical intervention was reported.The user states he discarded his device since the machine no longer functioned.No product is returning for investigation.The manufacturer concludes that we are unable to confirm the user's allegations due to the device not returning.We will be submitting this report as an initial final report.If additional information is obtained, we will submit a follow up report.No further action is necessary at this time.

Manufacturer Narrative

Correction to initial report: other serious or important medical events was checked in error.There was no harm associated with the reported malfunction.

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 previously received information allegingshortness of breath, headaches, very tired and has a hard time waking up in the morning.Related to cpap device.The patient did not report to receive medical intervention.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.Themanufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at thistime.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h7 and h9 corrected 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: 13236012
• MDR Text Key: 283668435
• Report Number: 2518422-2022-00767
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

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: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/30/2021; 07/05/2023
• Supplement Dates FDA Received: 07/06/2022; 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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
• Treatment: HUMIDIFIER - NO SN GIVEN
• Patient Outcome(s): Other
• Patient Sex: Male