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

Model Number UDSX500S11F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Epistaxis (4458)

Event Date 12/09/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging dissatisfaction and harm while on the replacement dream station auto cpap device.The patient alleges she does not like the device.The patient also alleges she used the device for a couple days and has been terribly dry upon waking up which led to sinus infections and a bloody nose.The patient stated she went to the doctor in which they prescribed her a antibiotic and nasal spray.The device was returned to the manufacturer.Investigation is anticipated but not yet begun.If any additional information is received, a follow up report will be filed.

• Brand Name: REP DREAMSTATION AUTO
• 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: 17117223
• MDR Text Key: 317047909
• Report Number: 2518422-2023-13382
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female