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

Model Number DSX500S11F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Epistaxis (4458)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The manufacturer became aware that a user of the dreamstation auto cpap alleging bloody nose and humidifier is not using any water.There was no report of serious patient harm or injury.Patient states he cleans his device weekly with warm water and a mild dish soap.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• 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: 18158492
• MDR Text Key: 328362502
• Report Number: 2518422-2023-30750
• 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

• 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
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male