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

Model Number UDSX500S11F

Device Problem Decrease in Pressure (1490)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816)

Event Date 12/14/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging the device tends to lose pressure during the night while on the replacement devastation auto cpap device.The user alleges his health has declined for the last six weeks of using the device.He stated that he has been to the doctor and 4 specialists ever since his health has declined due to the replacement device.The patient stated that his a-fib is more active since he began the device which prompted him to go to the cardiologist.The user alleges shortness of breath, muscle fatigue, headaches, fatigue, bone marrow producing to much due to lack of oxygen.The device was returned to the manufacturer.Investigation is anticipated but not yet begun.A follow up report will be filed after the investigation is complete.

Manufacturer Narrative

The manufacturer received information alleging the device tends to lose pressure during the night while on the replacement dreamstation auto cpap device.The user alleges his health has declined for the last six weeks of using the device.He stated that he has been to the doctor and 4 specialists ever since his health has declined due to the replacement device.The patient stated that his a-fib is more active since he began the device which prompted him to go to the cardiologist.The user alleges shortness of breath, muscle fatigue, headaches, fatigue, bone marrow producing to much due to lack of oxygen.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: 17060763
• MDR Text Key: 316573213
• Report Number: 2518422-2023-12717
• 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,Followup

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: 02/28/2023
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2021
• 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: 68 YR
• Patient Sex: Male