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

Model Number DSX520H11C

Device Problem Computer Software Problem (1112)

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

Event Date 11/22/2021

Event Type  malfunction  

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: the pca(printed circuit assembly) had q4 (phase c) of the motor circuitry blown apart.Q3 (phase b) of the motor circuitry of the pca had brown corrosion and black burn marks all around it.There was a black burn mark on the opposite side of the pca under the q3 area and there was unknown white residue in the area, also.There was dust-like contamination at the end of the iso port tube.All of this corrosion and unknown white residue signals that moisture potentially got inside of the device, suggesting liquid ingress as the root cause.Moisture potentially dripped onto the pca causing destruction, as seen with previous dreamstation 2 investigations with similar consequences.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.

Manufacturer Narrative

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

• Brand Name: DS2ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17603553
• MDR Text Key: 321743256
• Report Number: 2518422-2023-20568
• 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

• 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: 08/12/2022
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1