MAUDE Adverse Event Report: DRIVE DRIVE MEDICAL; FOAM MATTRESS

Model Number 15019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 01/11/2021

Event Type  Death  

Event Description

Pt was found with knees on floor, torso between bed rails, face down on mattress.Pt deceased.Family contacted the state police - (b)(6) 2021 program contacted state police for report.They will not release report program will need to subpoena for record.(b)(6) called, reports it will take approximately 10 weeks before they are able to provide us cause and manor of death.

• Brand Name: DRIVE MEDICAL
• Type of Device: FOAM MATTRESS
• Manufacturer (Section D): DRIVE; chicago IL 60673
• MDR Report Key: 11245132
• MDR Text Key: 229342319
• Report Number: 11245132
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/14/2021

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 Operator: Lay User/Patient
• Device Model Number: 15019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2021
• Distributor Facility Aware Date: 01/11/2021
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 109