MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DRIVE; CPAP

Model Number	INTELLIPAP
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Death
Event or Problem Description
Devilbiss healthcare was notified of a fire that occurred in a house where a patient was using a devilbiss cpap machine, along with several other electrical appliances.The insurer for the house reported that "preliminary investigation determined the fire was caused by a cpap system leading to property damage and loss of life." devilbiss has participated in the inspection of the fire scene with several parties and will continue to participate in the investigation of the cause and origin of the fire, and will provide an update when additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: CPAP
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jillian forster ; 99 seaview blvd; ste 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 15052841
• Report Number: 2515872-2022-00058
• Device Sequence Number: 5489272
• Product Code: BZD
• UDI-Device Identifier: 00885304001843
• UDI-Public: 00885304001843
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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?: No
• Device Model Number: INTELLIPAP
• Device Catalogue Number: DV51D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male