MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2 ADVANCED AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Epistaxis (4458)

Event Date 02/04/2023

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation of "humidifier not working" on a dreamstation2 adv.Auto device.The user stated she got a nose bleed, so she increased the humidity level to 5 on her device.The user takes blood thinners due to a history of heart attack and a stent that was put in her heart.The bloody nose would not stop so the user went to the er where they were able to stop the bleeding.User was discharged home.The next morning the nosebleed started again but was much worse, the user was advised by her physician to go to the ent doctor where a rhino rocket was inserted in her nose for four days and then removed.The user was also placed on prescription antibiotics for twelve days.The user stated she believes the nose bleeds were due to the device not providing enough humidity and the addition of blood thinners.The user did state since she has increased the humidity output setting, the dryness issue has been resolved.No device is returning for investigation.The user was able to increase the humidity level and the device is working properly.The manufacturer is submitting an initial- final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

Device not returned for evaluation.

Manufacturer Narrative

The manufacturer previously reported information of an allegation of "humidifier not working" on a dreamstation2 adv.Auto device.The user stated she got a nose bleed, so she increased the humidity level to 5 on her device.The user takes blood thinners due to a history of heart attack and a stent that was put in her heart.The bloody nose would not stop so the user went to the er where they were able to stop the bleeding.User was discharged home.The next morning the nosebleed started again but was much worse, the user was advised by her physician to go to the ent doctor where a rhino rocket was inserted in her nose for four days and then removed.The user was also placed on prescription antibiotics for twelve days.The user stated she believes the nose bleeds were due to the device not providing enough humidity and the addition of blood thinners.The user did state since she has increased the humidity output setting, the dryness issue has been resolved.In the previous report, section h1 type of reportable event was selected as "other".It has been corrected to "serious injury" on this report.In addition, a correction has been made to section d3 for the manufacturing site.

• Brand Name: DREAMSTATION2 ADVANCED 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: 16459152
• MDR Text Key: 310416943
• Report Number: 2518422-2023-05978
• 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: 02/15/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2022
• 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: 70 YR
• Patient Sex: Female