MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Contamination (1120); Patient-Device Incompatibility (2682)

Patient Problem Respiratory Tract Infection (2420)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

The manufacturer became aware that a user of the dreamstation 2 advanced auto cpap had seen white residue on the inlet filter and was given an antibiotic for respiratory issues.A week later the user was taken to the emergency room and admitted to the hospital.Originally the user was tested for meningitis.The user stated they clean the equipment with vinegar and water.The user was advised that this machine is not part of the recalled devices.The manufacturer has not received the devices for investigation.Despite multiple requests, no device has been returned.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

Device not returned.

Manufacturer Narrative

Corrected data includes changing the type of reported complaint to: product problem.

Manufacturer Narrative

On previously submitted report, section "type of reported complaint" in box h was incorrect.In this report section "adverse event/product problem","outcomes attributed to ae" in box b and "type of reported complaint" in box h has been updated/corrected.

• Brand Name: DS2ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16131268
• MDR Text Key: 307193865
• Report Number: 2518422-2023-01174
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male