MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2ADV CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number CAX521H12C

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 12/23/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap had no power to the unit and had a burning smell.There was no report of smoke, flames, voids, or exposed ac wires.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned to the manufacturer for investigation.During the evaluation of the device, the service technician was able to confirm the customer's complaint of the device had no power to the unit.The service technician confirmed the therapy pca was not working.The technician found thermal damage to the therapy pca, lcd display, center enclosure, and the blower box assembly.The technician was unable to download the error log data.The device was forwarded to the product investigation lab for further investigation.At this time, no further investigation has been performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION2ADV 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: 18547522
• MDR Text Key: 333286293
• Report Number: 2518422-2024-03608
• 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: Foreign,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: 01/19/2024
• 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: 04/18/2023
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female