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

Model Number DSX520H11C

Device Problem Smoking (1585)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging customer tried to plug the unit in and device got warm to the touch and smoke started to come out of the sd card reader.The customer also alleges that the device is not powering on and has an odor.The device was returned to the manufacturer's quality product investigation laboratory (pil) for evaluation.During the evaluation of the device pil observed an unknown dust contaminant on the water tank lid and tank seal.Dark hair-like particles were observed on the tank seal.The water tank pan was observed to have corrosion to it.An unknown dust contaminant was observed on the ui panel, as well as brown burn-like contaminant.An unknown dust contaminant was observed on the top enclosure and center enclosure.Evidence of liquid ingress was observed to the iso port.The iso was also observed to have burn marks on it, possibly from the pca.The pca was observed to have burning of the q3, as well as corrosion to other areas of it.The issue of liquid ingress to the pca has been previously investigated as documented in capa 3376332.An unknown dust contaminant was observed inside the inlet of the blower box, on the inlet/outlet seal, on the blower, blower seal, blower box, heater plate, and bottom enclosure.Evidence of liquid ingress was observed to the heater plate and bottom enclosure.Pil was able to confirm a burning smell coming from the device.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18946819
• MDR Text Key: 338207342
• Report Number: 2518422-2024-14592
• 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: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male