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

Model Number DSX520H11C

Device Problems Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 11/14/2022

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 will not power on.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.External investigation found no significant observations.Using the returned power supply and cord, pil applied power to the device and confirmed the unit does not power on.Shortly after applying power the technician observed a burning electronics odor and removed power from the device.Internal investigation found thermal damage to the q2 and c44 on the top side of the pca.Physical damage and contamination were observed on pads in the vicinity of the failed components.Evidence of thermal stress (smoke residue and discoloration) was observed on the underside of the touchpad component of the ui panel.No evidence of water ingress was visible on the interior of the ui panel, the interior of the rear panel, or on/in the iso tube.Microscopic review of the pca found a fine blue-green powder and an orange-brown substance between the corner of q2 and the through-hole pad of r248.The two through-hole pads closest to the q2¿s white orientation dot show evidence of solder leaching, one of which also shows evidence of damage to the substrate beneath the pad.Pil was able to confirm the complaint but is not able to confirm the service technician¿s evaluation that it is due to water ingress.Q2 and c44 show thermal damage, there are unidentified contaminates on the pca in the vicinity of the damage, and there is unusual leaching and physical damage to eye pads.

• Brand Name: DREAMSTATION 2 ADV AUTO CPAP 2
• 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: 16880021
• MDR Text Key: 314673352
• Report Number: 2518422-2023-10549
• 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: Other Health Care 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: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1