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

Model Number DSX200T11C

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Dry Mouth (4485)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The manufacturer received information alleging waking up with dry mouth, fatigue and the device is not taking water, and also has strange odor.There was no report of patient harm or injury.The device was returned to a third-party service center for evaluation.There was no evidence of visible foam particles.The customer's complaint could not be confirmed.In addition, the device was scrapped.

Manufacturer Narrative

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

• Brand Name: DREAMSTATION 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: 17839729
• MDR Text Key: 324571531
• Report Number: 2518422-2023-24822
• 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
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX200T11C
• Device Catalogue Number: DSX200T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1