MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation 2 device would not turn on.It was alleged the last time the device was operating it smelled like it was burning.The device was returned to the pil (product investigation lab).When the device was plugged in, a strong burning odor was observed.The technician removed power from the device.The error logs and care orchestrator data were not able to be retrieved.During the investigation, pil removed the ui panel and observed burn marks on the underside of it.The top enclosure was observed to have warping, burn marks, and a melting appearance to it, and was difficult to remove from the device.The center enclosure also was observed to have warping, burning, and melting.The pca was observed to have heavy burning and corrosion on it in several locations, including the following: q6, q7, d9, q1, fb2, fb3, d4, c76, d6, d8, d11, c202, c193, d10, and surrounding areas.The heater plate connection cable was heavily burnt and melted and was not able to be removed from the pca.The blower box and blower connecter were observed to have melted and had burn marks on them likely due to the thermal event of the pca.An unknown dust contaminant was observed inside the inlet of the blower box, confirming debris in the airpath.An unknown dust contaminant was also observed on the blower, blower seal, and blower box.The heater plate was observed to have a discoloration to it, possibly due to liquid ingress to it.An unknown dust contaminant was observed on the bottom enclosure.The heater plate spring was observed to have a slight discoloration to it.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.

• Brand Name: DS2ADV 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19114864
• MDR Text Key: 340690404
• Report Number: 2518422-2024-19772
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female