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

Model Number CAX521H12C

Device Problems Use of Device Problem (1670); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : not returned to the manufacturer.

Event Description

The manufacturer received information alleging "the water tank was empty" and the air was very hot."the patient does not have heated tubing and the humidifier was set at 2 at the time." the patient alleges they woke up during the night and felt the inside of their nose was burnt and started to blister.The patient has reached out to the dme and was asked to bring their unit in, however they needed to use it for their therapy.The dme advised the patient to contact their physician, who then stated the patient requires a new equipment as their "unit is defective." there is no allegation of serious or permanent harm or injury.Medical intervention was not specified.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 alleging "the water tank was empty" and the air was very hot."the patient does not have heated tubing and the humidifier was set at 2 at the time." the patient alleges they woke up during the night and felt the inside of their nose was burnt and started to blister.The patient has reached out to the dme and was asked to bring their unit in, however they needed to use it for their therapy.The dme advised the patient to contact their physician, who then stated the patient requires a new equipment as their "unit is defective." there is no allegation of serious or permanent harm or injury.Medical intervention was not specified.The device was returned to the manufacturer for investigation.During the evaluation of the device, the manufacturer found evidence of liquid ingress with mineral deposits on the water tank, tank seal, tank lid, and inlet/outlet seal.There was evidence of liquid ingress on the top enclosure and the iso port.The filters were observed to have unknown dust contaminant on them and were very dark in color.An unknown dust contaminant was observed on the top enclosure, therapy button, inside the inlet of the blower box, on the blower, on the blower box, and bottom enclosure.The manufacturer confirmed that the device powered on, provided airflow, had a known good heated tube that heats, and the heater plate heats.A heat test was performed twice on the device, heater plate, and patient port - once with an empty water chamber and once with a full water chamber.The results showed that the device, heater plate, and patient port all showed temperatures within the required threshold.

• 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: 18058525
• MDR Text Key: 327204139
• Report Number: 2518422-2023-28657
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX521H12C
• Device Catalogue Number: CAX521H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male