MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DEX900S13

Device Problem Contamination (1120)

Patient Problem Cough (4457)

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging a user of a dreamstation autosv device has dark deposits which keep accumulating on the edge of the sleep mask.The user states this may be caused by the device.The user also alleges a chronic cough.The patient has been using several autosv systems since (b)(6), 2011.The device affected is an fco replacement device which has been in use since (b)(6), 2022.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18413988
• MDR Text Key: 331552635
• Report Number: 2518422-2023-38385
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090539
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEX900S13
• Device Catalogue Number: DEX900S13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1