MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number UDSX500S11F

Device Problems Fire (1245); Device Emits Odor (1425); Unexpected Shutdown (4019)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

The manufacturer received information alleging of a thermal event to a replacement dreamstation auto cpap device.The user alleges the device shut off and when he woke up, he smelled an electrical odor, and the power supply felt warm.The user alleges there was corrosion around the power cord and when he attempted to wipe it with a tissue, the tissue caught on fire.The user states he extinguished the flame with his hand.There was no report of patient harm or injury.The device has not returned to the manufacturer.The manufacturer's investigation is ongoing.A final report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16130973
• MDR Text Key: 307001798
• Report Number: 2518422-2023-01171
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male