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

Model Number DSX500T11

Device Problem Degraded (1153)

Patient Problem Chest Pain (1776)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

Event Description

The patient contacted the manufacturer, stating that he owns a dreamstation cpap device.The user has alleged chest paints; however, they did not claim that they are associated with device usage.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 18744935
• MDR Text Key: 336543088
• Report Number: 2518422-2024-08732
• 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: Other,Distributor
• 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: Other
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1