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

Model Number CAX521H12C

Device Problems Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 03/10/2023

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 device was loud.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 was unable to confirm the complaint of the device being loud.The technician found thermal damage to the pca at q2 and q3.There was evidence of water ingress to the cpa.Evidence of water ingress to the blower and thermal stress to the lcd touch display was also found.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturer previously reported information received alleging of a thermal event to a dreamstation 2 advanced auto cpap device.The user alleges the device was loud.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 was unable to confirm the complaint of the device being loud.The technician found thermal damage to the pca at q2 and q3.There was evidence of water ingress to the cpa.Evidence of water ingress to the blower and thermal stress to the lcd touch display was also found.On the previously submitted report, the reporter country in section e was listed incorrectly as the united states.The country should have been listed as "canada".It is corrected on this report.Box e - updated reporter information including reporter country.

• 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: 16881992
• MDR Text Key: 314973180
• Report Number: 2518422-2023-10554
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/10/2023

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: CAX521H12C
• Device Catalogue Number: CAX521H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1