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

Model Number DSX500S11F

Device Problem Degraded (1153)

Patient Problem Pain (1994)

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device has not been returned to the manufacturer.

Event Description

The manufacturer received information regarding a dreamstation auto cpap.The patient has alleged visualization of white particles and nose hurts.There was no report of serious or permanent patient harm or injury.The manufacture's investigation is ongoing.A follow up report will be submitted.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 18777819
• MDR Text Key: 336211556
• Report Number: 2518422-2024-09716
• 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: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11F
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1