MAUDE Adverse Event Report: RESPIRONICS, INC. DREAM STATION2 ADVANCED AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2023

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The manufacturer became aware of a thermal event while using the dream station 2 device.The user stated that they smelled and saw smoke, unplugged device and saw flames, and blew the flames out.They stated it smelled of burning plastic.There was no damage to the power accessories.There was no patient harm or injury reported.The device has not yet been returned for investigation.The manufacturer's investigation is ongoing.A follow up report will be submitted when the investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a thermal event while using the dream station 2 device.The user stated that they smelled and saw smoke, unplugged device and saw flames, and blew the flames out.They stated it smelled of burning plastic.There was no damage to the power accessories.There was no patient harm or injury reported.The manufacturer received the device for investigation.External examination observed minor wear and tear such as light scuffing on the ui bezel and dust/dirt/indeterminate contamination on the bottom of the device.Multiple cracks in the bottom enclosure around both screw holes suggest over-tightening.Mineral deposits were observed throughout the interior of the water tank, on the humidifier seal, in the iso port tube at both ends, on the exterior of the rear panel, on the underside of the bottom enclosure, in the dc power cord channel, and on the heater plate.This suggests multiple spills and the use of non-distilled water in the device.The internal investigation observed discoloration of the underside of the touchscreen component and its label.Extensive evidence of mineral deposits, liquid ingress, and/or corrosion were observed on the underside of the ui panel, on both sides of the pca, on the top exterior of the iso port tube, and on the heated tube end of the heated tube jumper/connector.Mineral deposits and dust/dirt contamination were observed in the blower box, on and in the blower, in the blower seal, as well as throughout the airpath.Mineral deposits were observed on the interior of the rear panel near the humidifier seal, on the interior of the bottom enclosure, on the underside of the heater plate, and on/under the heater plate spring.A bottom enclosure screw boss was broken.Significant dust and fibrous contamination was observed at the air inlet.Using a known good power supply and cord, pil powered on the device.Device booted successfully; however, airflow was not initiated due to the damage to the pca (damage to q2, q3, or q4 would likely prevent blower functionality).Pil retrieved the device logs.The 11 errors occurred within 10 minutes of each other on 20mar2023, the date of the alleged incident.Given the extensive evidence of mineral laden liquid ingress to the entire device, it is likely these errors were generated as a result.The manufacturer is able to confirm thermal damage to the pca, likely due to mineral laden liquid ingress.Pil found no voids, charring, or bubbling in the plastic to support flames being visible.

• Brand Name: DREAM STATION2 ADVANCED AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16742559
• MDR Text Key: 313309433
• Report Number: 2518422-2023-08926
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female