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

Model Number DSX520T11C

Device Problem Insufficient Heating (1287)

Patient Problem Epistaxis (4458)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information regarding a dreamstation 2 cpap device not working correctly.The patient states the humidifier stops working and uses "a little bit of water" with "no damages on the humidifier." they were using a non-heated tubing with the humidity set to 5 and pressure set to 10.The patient alleges nose bleeds and had gone to the emergency due to a bloody nose.Per their doctor, "the blood vessel was ruptured due to dry air," and it was cauterized inside their sinuses.The doctor advised to have the device fixed.There is no allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information regarding a dreamstation 2 cpap device not working correctly.The patient states the humidifier stops working and uses "a little bit of water" with "no damages on the humidifier." they were using a non-heated tubing with the humidity set to 5 and pressure set to 10.The patient alleges nose bleeds and had gone to the emergency due to a bloody nose as they "tempted to have it stop but it never did." per their doctor, "the blood vessel was ruptured due to dry air," and it was cauterized inside their sinuses.The doctor advised to have the device fixed.Upon further review, this event was determined to be both a product problem and serious injury.In this report, sections b1, h1, and h6 (health impact) has been corrected.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18395274
• MDR Text Key: 331420531
• Report Number: 2518422-2023-37783
• 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: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male