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

Model Number DSX520T11C

Device Problem Computer Software Problem (1112)

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

Event Date 11/22/2021

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 the dreamstation 2 advanced auto cpap device service required message.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.External and internal inspection of the device and observed the following: pca(printed circuit assembly) had q3 (phase b) of the motor circuitry was blown apart.There was a brown burn mark on the opposite side of the pca near d22 where q3 was located on the topside and on the iso port tube that was under the q3 component.There was unknown white residue and brown corrosion on the traces near d32.There was unknown white residue and black corrosion near d21 and d19.There was unknown white residue on 2 of the screws that hold the pca in place.There was unknown white residue at the pins of j5.Observed the various unknown white residue and that they may be potential mineral deposits, suggesting water ingress on the pca as the root cause.The blower box was free of contamination, as observed with a visual inspection.There is visible damage or functionality failures of the device, most likely due to external conditions.Potential moisture getting into the device where the pca is located and is believed to be the primary cause of the customer complaint.

• 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: 17603803
• MDR Text Key: 321747383
• Report Number: 2518422-2023-20569
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• 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 Returned to Manufacturer: 08/05/2022
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1