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

Model Number DSX500T11

Device Problem Patient-Device Incompatibility (2682)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation auto cpap device caused an end user to have recurring sinus infections.Allegedly, the doctor agrees and feels the cpap is giving the patient sinus infections and wants the patient to have a new device.There was no report of serious patient harm or injury.There was no report of medical intervention.The device was returned to the manufacturer for evaluation.During the evaluation of the device, the device was visually inspected, and found evidence of white colored talc-like contaminant on the filters in air inlet port and in the air-path.The finding of contaminants in the air inlet ports indicates the source of the contaminants is external to the devices and is not related to a failure of the devices.The device was scrapped, the customer's complaint could not confirm and no error code found.

• Brand Name: DREAMSTATION 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: 17904887
• MDR Text Key: 325289059
• Report Number: 2518422-2023-25843
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female