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

Model Number CAX500T12C

Device Problem Contamination (1120)

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The manufacturer received information regarding a dreamstation auto cpap device.The device was returned to a third-party service center.During visual inspection of the device, connector oxide contamination was found on the device.In addition, tobacco contamination in device was present, and the device was scrapped.This report is being submitted for the connector oxide contamination was found on the device during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• 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: 18509778
• MDR Text Key: 332907913
• Report Number: 2518422-2024-02403
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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: CAX500T12C
• Device Catalogue Number: CAX500T12C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2023
• Initial Date FDA Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1