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

Model Number DSX700H11C

Device Problem Power Problem (3010)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/14/2022

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation of a thermal event on a dreamstation auto bipap device in a memory care facility.The wife states there was a burning odor and smoke but no flames were seen.The user was given oxygen for the smoke inhalation.There was no other medical intervention reported.No product will be returning for investigation.The user's wife discarded the device with power accessories and humidifier.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs).It is for use in the home or hospital/institutional environment.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.Contact your home care provider." the power supply is designed in accordance to iec 60601 and applicable parts of iec 60950.Voltage in the cpap/humidifier device is limited to 12 v dc nominal, and current is limited by the device fuse, to minimize the potential for electrical fire.The design of the electronics mechanical's are robust enough to resist damage that would result from typical usage.This report will be sent as an initial final.If additional information is received, a supplemental report will be filed.

Manufacturer Narrative

Corrected h1 to serious injury.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 15140201
• MDR Text Key: 301122318
• Report Number: 2518422-2022-66426
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: Health Professional
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER NO SN INFORMATION
• Patient Outcome(s): Other
• Patient Sex: Male