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

Model Number UDSX500S11F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 02/19/2024

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation that an end user developed a lung disease while using a rep dreamstation auto cpap.The device was returned to a third-party service center.During evaluation of the device, the third-party service center visually inspected the device and found no evidence of foam particles or degradation.Secondary findings include scratched lcd screen, damaged buttons on upper enclosure.In addition, the device settings were corrected.Lastly the device passed the final test.

Manufacturer Narrative

H3 other text : device returned to third party service center for evaluation.

• Brand Name: REP 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: 19035713
• MDR Text Key: 339285982
• Report Number: 2518422-2024-17167
• 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: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other