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

Model Number DSX200H11

Device Problems Degraded (1153); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device serviced by third party service center.

Event Description

A device was returned to a third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device, the third-party service center visually inspected the device and evidence of foam degradation was found.There were secondary findings that the device could not hold the pressure.The device was scrapped.

• 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: 18009685
• MDR Text Key: 326587665
• Report Number: 2518422-2023-27832
• 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: Company Representative
• 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: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX200H11
• Device Catalogue Number: DSX200H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2018
• 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