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

Device Problem Insufficient Information (3190)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The manufacturer was contacted about a dreamstation 2 device via a voluntary medwatch (mw5152132).The user alleges they received a replacement device after recalling their previous device.The user complains of congestion and a consistent troublesome cough.They believe these symptoms are due to device usage.The user did inform his pulmonologist and has visited their doctor on numerous occasions to remedy the symptoms.The user allegedly was instructed by the manufacturer to cease using the device temporarily (for two days).The user resumed using the device because of his health condition.

• Brand Name: DREAMSTATION 2
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19057301
• MDR Text Key: 339775617
• Report Number: 2518422-2024-17935
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1