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

Model Number DSX500S11

Device Problem Degraded (1153)

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

Event Date 01/24/2023

Event Type  malfunction  

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.The device was not in patient use.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation.During the evaluation, foam particles were observed; and device was scrapped.In addition, the third-party service center recognized a system error had occurred on the device but did not specify the type of error that had occurred on the device.

• Brand Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Type of Device: DREAMSTATION AUTO CPAP
• 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: 19212264
• MDR Text Key: 341372782
• Report Number: 2518422-2024-23741
• 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: User Facility
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX500S11
• Device Catalogue Number: DSX500S11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1