MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The patient reported to philips that while using the dream station 2 advanced auto cpap device and mask was thermal smell and burnt his nose.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The patient previously reported to philips that while using the dream station 2 advanced auto cpap device and mask was thermal smell and burnt his nose.The previous report included serious injury for the type of reported complaint, which is incorrect.The following sections were corrected: b1, b2, h1 and health impact grid.This report is being filed to correct this information.

• Brand Name: DREAMSTATION 2 ADV 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: 17958759
• MDR Text Key: 325965301
• Report Number: 2518422-2023-27126
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male