MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; 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 03/21/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging of a thermal event to a dreamstation 2 advanced auto cpap device.The user alleges the unit will no longer power 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 opened the device and found significant evidence of water damage on the pca.Thermal damage to q2 was also found.The technician observed the device does not power on (dead device).

Manufacturer Narrative

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

• 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: 16882309
• MDR Text Key: 314836003
• Report Number: 2518422-2023-10571
• 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

• Date FDA Received: 05/05/2023
• 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: 03/21/2023
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1