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

Model Number CAX400H12

Device Problem Calcified (1077)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  Death  

Event Description

The manufacturer received information alleging a patient of a dreamstation cpap pro passed away.The manufacturer received information from a representative from quinte cpap inc that the device was returned and replaced, however the patient is deceased.No further information about the patient's cause of death could be provided to the manufacturer.The device was returned to a third-party service center for investigation.During the evaluation of the device, the third-party service center visually inspected the device and found calcium residue.There was no evidence found of any foam particles during the evaluation.The device has been scrapped.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: DREAMSTATION CPAP PRO
• 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: 17951645
• MDR Text Key: 325869661
• Report Number: 2518422-2023-26647
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX400H12
• Device Catalogue Number: CAX400H12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death