MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Smoking (1585); Complete Loss of Power (4015)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Corrective and preventative actions have been opened by the manufacturer to address the water ingress identified upon investigation.

Event Description

The manufacturer received information alleging that the dreamstation 2 advanced auto cpap device circuitry is smoking after 20 minutes of running and the "service required" message comes up.The user also alleges the device will not turn on.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.During the evaluation, the technician verified the device would not power on; therefore, functional testing was unable to be performed.No error log information was able to be obtained.A visual external and internal inspection of the device was performed which found the following: the back of the ui (user interface) display had potential black and brown burn marks on it and the ribbon cable had white residue resembling potential mineral deposits.Q3 (phase b) of the motor circuitry, on the pca (printed circuit assembly), was blown apart along with surrounding components and some white residue (resembling potential mineral deposits) was present with unknown brown contamination.Bottom screw of the enclosure has white residue (resembling potential mineral deposits) on it.Iso port tube had unknown brown corrosion on it at the part that sits under q3 of the pca.White residue, resembling potential mineral deposits, was found at d31 of the pca and the surrounding area along with potential black corrosion at a circuit via.One of the pca screws had white residue on it, resembling potential mineral deposits.On the underside of the pca where q2 is located, there was potential unknown brown corrosion along with white residue, resembling potential mineral deposits.On the underside of the pca at r99 there is potential black corrosion.Tiny unknown white, black and brown specs of contamination were at the bottom of the blower box.There were potential mineral deposits on the bottom of the blower motor, bottom of the blower box and on the bottom of the enclosure.The evaluation of device concluded that the potential mineral deposits on the bottom of the blower box and the blower motor indicates water ingress.Potential moisture getting into the device where the pca is located is believed to be the primary cause of the reported symptoms.

• Brand Name: DREAMSTATION 2 ADV 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: 16880961
• MDR Text Key: 314722384
• Report Number: 2518422-2023-10551
• 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: 05/25/2022
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male