MAUDE Adverse Event Report: RESPIRONICS, INC. / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION AUTO CPAP MACHINE

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Last night my philips respironics dreamstation auto cpap machine stopped and woke me up.As i looked at the machine there was smoke coming out of the machine.The smoke filled the room.There were burn marks on the bottom of the machine and it was very hot.Device is no longer usable.Retailer: (b)(6).Retailer state: (b)(6).Purchase date: (b)(6) 2019.(b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC. / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
• MDR Report Key: 8491583
• MDR Text Key: 141318301
• Report Number: MW5085629
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/24/2019

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?: No
• Device Operator: No Information
• Device Model Number: DREAMSTATION AUTO CPAP MACHINE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR