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

Model Number DSX500H11C

Device Problem Contamination (1120)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by a third-party service center.

Event Description

The manufacturer was contacted by a dreamstation auto cpap user.The device was returned to a third-party service center and was visually inspected and evaluated.During the device evaluation at the third-party service center, the device was visually inspected/scrapped and found evidence of foam degradation.During the evaluation, there was no evidence of foam degradation.There was the presence of dirt contamination and bug infestation.The device was scrapped.

Manufacturer Narrative

The manufacturer previously reported information regarding a dreamstation auto cpap device.The device was returned to a third-party service center and was visually inspected and evaluated.During the device evaluation at the third-party service center, the device was scrapped.During the evaluation, there was no evidence of foam degradation.There was the presence of dirt contamination and bug infestation.In the previous report, the reporter country was omitted.It has been corrected in this report.

• 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: 18437355
• MDR Text Key: 331820143
• Report Number: 2518422-2024-00328
• 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: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1