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

Model Number DSX500H11C

Device Problems Fire (1245); Smoking (1585); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

The manufacturer became aware that a user experienced a thermal event with his dreamstation auto cpap device.The user saw smoke and a flame had come out when unplugging the dc power supply from the device.The flame extinquished on its own.There was no patient harm or injury reported.The device, humidifier, modem and power accessories have returned for evaluation but have not yet been investigated.A follow up final will be filed after the investigation has been completed.

Manufacturer Narrative

The manufacturer previously reported that a user experienced a thermal event with his dreamstation auto cpap device.The user saw smoke and a flame had come out when unplugging the dc power supply from the device.The flame extinguished on its own.There was no patient harm or injury reported.The device was returned to the manufacturers product investigation laboratory and the customers complaint was confirmed.External investigation found discoloration consistent with rust and smoke contamination around and in the dc input plug.Black marks consistent with melted black plastic were also observed on both the base unit and humidifier to the left of the.Using the returned power supply and cable, the technician applied power to the base unit.The unit began to power up, but the technician observed the p4 connector immediately began smoking and removed power from the device.Internal investigation found a brownish discoloration on the blower box assembly directly above the p4 connector.The p4 connector itself displayed evidence consistent with rust and oxidation.The technician observed discoloration consistent with rust on the interior of the bottom enclosure in the vicinity of the p4.Starting in the interior corner of the bottom enclosure closest to the air intake port, several liquid drips marks can be traced stopping just short of the center of the front panel joint.Using a known good p4 connector, the technician applied power to the pca and all subsequent components.Device powered on and provided airflow without further thermal event.The technician is able to confirm a thermal event occurred.The likely cause of the thermal event is due to corrosion caused by liquid ingress to p4.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/CELL, DOM
• 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 15206 ; 2673970028
• MDR Report Key: 13375196
• MDR Text Key: 284609307
• Report Number: 2518422-2022-01954
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER -SN (B)(4)CELLULAR MODEM
• Patient Age: 55 YR
• Patient Sex: Male