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

Model Number UDSX500S11F

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problems Dyspnea (1816); Unspecified Nervous System Problem (4426)

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information regarding a repaired dreamstation auto cpap device alleging the device/humidifier is overheating, does not work, and is "not cooling down." the patient noticed " a plastic burn smell occasionally" and states "it does not last long," however it has been going on for a while and "is really affecting [them]." within five seconds, the humidifier is "already heated" and "occurs regardless of whether the humidifier is set at 1 or 5." the "tube is sometimes hotter than normal" and heats up when the patient is not using a heated tube.Prior to the issues beginning, "there was water outside the water chamber and on the heater plate." the "whole device was wet," which the patient "wiped it up and put it back together" and has not encountered the issue since.The patient alleges their "teeth are going bad" and their "mouth is like cotton all night." they "had to get a partial and now has to get a full upper plate" and "this issue interferes with [their] sleep." they sometimes will awaken "gasping for air because [they] cannot breathe through [their] mouth," feeling more tired during the day, and sometimes "feels short of beath." there was 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.

• 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: 18882567
• MDR Text Key: 337463698
• Report Number: 2518422-2024-13338
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female