MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Dyspnea (1816)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The manufacturer received information from an end user's wife alleging a dreamstation 2 advanced auto cpap device contributed to her husband having a hard time breathing and developing a sinus infection.The end user allegedly visited a doctor and was prescribed antibiotics.The end user reportedly was not using filters on his machine.There was no report of serious patient harm or injury.The end user reported using an ozone-based disinfection device to clean his machine.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.

Manufacturer Narrative

The manufacturer previously reported information from an end user's wife alleging a dreamstation 2 advanced auto cpap device contributed to her husband having a hard time breathing and developing a sinus infection.The end user allegedly visited a doctor and was prescribed antibiotics.The end user reportedly was not using filters on his machine.There was no report of serious patient harm or injury.The end user reported using an ozone-based disinfection device to clean his machine.In the previous report, section h1 type of reportable event was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

• Brand Name: DREAMSTATION 2 ADV 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: 16724764
• MDR Text Key: 313137046
• Report Number: 2518422-2023-08727
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2022
• 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: 79 YR
• Patient Sex: Male