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

Model Number DSX700T11C

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

The manufacturer became aware that a user awoke to a thermal event with her dreamstation auto bipap device.User stated there was an error message the previous day, but she was not sure what it said.The barking dog awoke the user during sleep.User states she saw flames at the filter door and a flaming blower assembly.User extinguished the flames with (b)(6).Unit is said to be charred and bubbled on the side.The patient uses oxygen with her bipap, it is unknown if a one-way valve was in place.User is a smoker.There was no patient harm or injury reported.The device with humidifier and modem have not yet returned for investigation.A follow up final report will be filed after the investigation is completed.

Manufacturer Narrative

The manufacturer previous reported that a user awoke to a thermal event with her devastation auto bipap device.The user stated there was an error message the previous day, but she was not sure what it said.The barking dog awoke the user during sleep.The user states she saw flames at the filter door and a flaming blower assembly.The user extinguished the flames with diet coke.The unit is said to be charred and bubbled on the side.The patient uses oxygen with her bipap, it is unknown if a one-way valve was in place.The user is a smoker.There was no patient harm or injury reported.The manufacturer received the device, humidifier, modem, power cord and supply and a non-philips air filter for evaluation.An engineering review concludes the most likely cause of the thermal event is ignition of oxygen in the airpath.The instructions for use state the proper use of oxygen with the devastation devices require a one-way valve which prevents the backflow of oxygen into the device.The user indicated oxygen was in use but did not indicate if a one way valve was used in the patient circuit.The user also indicated that the patient or a household member is a smoker which could have been a potential source of ignition.For the oxygen.The mask and tubing were not returned so these could not be assessed for damage or if the required one-way valve was in place.The investigation lab is able to confirm the complaint of a thermal event but they are unable to confirm the allegation of spontaneous combustion.The root cause is assumed to be ignition of the oxygen in the airpath.Due to the extensive thermal damage, the sound abatement foam was unable to be evaluated for evidence of degradation.The manufacturer concludes no further action is needed at this time.There was no patient harm or injury.

• Brand Name: DREAMSTATION AUTO BIPAP W/HUM/HT/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: 13440888
• MDR Text Key: 284971987
• Report Number: 2518422-2022-03018
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER -H29557816699FOXYGENMODEM
• Patient Age: 70 YR
• Patient Sex: Female