MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DRIVE; CPAP

Model Number INTELLIPAP

Device Problem Fire (1245)

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

Event Date 12/09/2021

Event Type  Death  

Event 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
• Type of Device: 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
• MDR Text Key: 296144336
• Report Number: 2515872-2022-00058
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00885304001843
• UDI-Public: 00885304001843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Sex: Male