MAUDE Adverse Event Report: MASON; ROTATION SYSTEM

Model Number LS9500

Device Problem Unintended Ejection (1234)

Patient Problems Death (1802); Injury (2348)

Event Date 12/09/2016

Event Type  Death  

Event Description

(b)(6) is the distributor of the device which is a (b)(6) branded pressure prevention system that is designed to provide continuous rotation at the required patient levels.(b)(6) became aware of the incident through legal action.We have no access to the device for investigation nor any of the required data for this report.The end-user was paralyzed from the waist down and was using the device to prevent bed sores/ulcers.The device was serviced multiple times by the provider since its first use in (b)(6) 2015.Two weeks after the last repair the end-user was sitting on the end of the bed eating when he was reportedly thrown from the bed.He suffered multiple broken bones in his legs.Following surgery to one leg two days later the end-user passed away.

• Brand Name: MASON
• Type of Device: ROTATION SYSTEM
• MDR Report Key: 7255610
• MDR Text Key: 99528935
• Report Number: 2438477-2018-00005
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LS9500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Distributor Facility Aware Date: 12/05/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death