MAUDE Adverse Event Report: ROHO, INC. ROHO DRY FLOATATION MATTRESS OVERLAY SYSTEM; NON-POWERED MATTRESS OVERLAY

Model Number MATTSYS

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problem Pressure Sores (2326)

Event Date 01/02/2014

Event Type  Injury  

Event Description

The patient developed a stage 3 pressure sore, which was diagnosed while the roho mattress overlay was in use.The facility's notes indicated that the patient was previously on a dynamic mattress and that there is a history of three of the same brand dynamic mattresses failing (deflating).The dynamic mattresses were not manufactured by roho, inc.In the period running up to (b)(6) there had been the third failure of this brand and a decision taken by the facility was to use a roho dry floatation mattress overlay system (roho mattress overlay) in case there was another failure of the dynamic mattress during a period when there was reduced staffing.The facility's report indicated that the roho mattress overlay was not set up correctly (over-inflated while in use) and two pieces were not connected as they should have been.The facility acknowledged the patient needed regular checking and had not been checked for a 10 day period.

Manufacturer Narrative

Roho has conducted an investigation and with information provided by their distributor, sumed, has concluded that the incident was user error based on information in this report and the following: the patient has very complex pmh and moving and handling issues, which the facility team did not review in accordance with facility policies.The patient developed a stage 3 pressure sore, which was diagnosed while the roho mattress overlay was in use.The facility's report indicated that the roho mattress overlay was not set up correctly (over-inflated while in use) and two pieces were not connected as they should have been.The facility reported the patient needed regular checking and had not been checked for a 10 day period.It has been reported by the lead tissue viability nurse at the facility that the patient should never have been changed from a dynamic system.The lead tissue viability nurse at the facility had to cancel specialist training that had been scheduled for (b)(4) 2013 due to pressures from senior managers within the trust.Sumed will work with the facility to schedule a new training session for the staff on proper use of roho mattress overlays.A comprehensive training plan will be finalized before the end of (b)(4) 2015.

• Brand Name: ROHO DRY FLOATATION MATTRESS OVERLAY SYSTEM
• Type of Device: NON-POWERED MATTRESS OVERLAY
• Manufacturer (Section D): ROHO, INC.; 100 north florida ave.; belleville IL 62221 542
• Manufacturer Contact: robin gergen ; 100 north florida ave.; belleville, IL 62221-5429 ; 6182228363
• MDR Report Key: 4522899
• MDR Text Key: 5545620
• Report Number: 1419507-2015-00001
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2015

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: MATTSYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/12/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention