MAUDE Adverse Event Report: DRIVE; MATTRESS

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2023

Event Type  Death  

Event Description

Devilbiss healthcare was notified of a complaint involving an electric bed by an insurance carrier, who stated that the bed was found in the area where a fire occurred, among other products.The fire caused the death of one person, as well as severe property damage regarding a fire damage loss subrogation.Drive is participating in the investigation of the fire and will file an update when additional information becomes available.

• Brand Name: DRIVE
• Type of Device: MATTRESS
• MDR Report Key: 17799157
• MDR Text Key: 324045306
• Report Number: 2438477-2023-00128
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2023
• Distributor Facility Aware Date: 08/24/2023
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female