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

Model Number DSX520H11C

Device Problem Excessive Heating (4030)

Patient Problems Dyspnea (1816); Unspecified Heart Problem (4454)

Event Date 12/04/2023

Event Type  Death  

Event Description

The manufacturer was contacted in reference to ds2adv auto cpap device.There was an allegation of difficulty breathing and patient passing away.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Device not yet returned to the manufacturer.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.The customer supplied power supply and ac power cord was used on the dream station 2.The device powered on, and airflow was verified.It was also verified that the heater plate and a heated tube were working.A 2.5-hour temperature test measuring the base surface, and the patient port airpath and all temperature levels were within specifications.With the humidifier level set to 0 (off), it was verified that the heater plate did not heat up.The patient port airpath maximum temperature recorded was 25°c and was within the temperature specifications.The air temperature at the end of the 22mm tube stayed at 25°c.A 15-minute test using a 6 foot (22mm) tube with a leak device (simulating a mask) and observed that the water does make a bubbling sound and that the device produced small water droplets at the end of the outlet port.The bubbling noise is typical operation when air is blown over water in a small water tank.The evaluation did not confirm the complaint that the air coming out of the device was warm.The evaluation did not confirm that the device will not work.The evaluation was able to confirm the complaint of the device making a bubbling noise, and that water dripping from the air outlet port of the tube.Device is found to be operating within specifications.In addition, dust-like contamination was noted on the air outlet port, blower motor, and bottom of the heater plate.The air inlet filter had a unknown gray contamination on it as well.The evaluation can confirm the presence of multiple contaminants that are likely from an external source.

• 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: 18819472
• MDR Text Key: 336691204
• Report Number: 2518422-2024-10993
• 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?: 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?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death