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

Model Number DSX500T11C

Device Problem Degraded (1153)

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

Event Date 12/24/2022

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.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to a third party service center for investigation.External examination of the unit found a scratched lcd screen and damaged buttons on upper enclosure.No other contamination was observed in the device.The device was powered on and is functional.The device's downloaded event log was reviewed by the third party service center and 0 errors were logged.The manufacturer confirmed the third party service center found evidence of sound abatement foam degradation.

• 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: 16076662
• MDR Text Key: 306520939
• Report Number: 2518422-2022-103412
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1