MAUDE Adverse Event Report: HILL-ROM INC ENVISION THERAPEUTIC SURFACE OVERLAY MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number E700

Device Problems Device Difficult to Setup or Prepare (1487); Improper or Incorrect Procedure or Method (2017)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/29/2014

Event Type  No Answer Provided  

Event Description

The envision mattress replacement was placed on a facility-owned bedframe.The air mattress was set to "max inflate." the two physical therapists were assisting the patient to the edge of the bed.The mattress seemed to come off of the opposite side of the bed that the patient was sitting up on.The air also moved in the mattress and it seemed to be "tipping" the patient off the bed.With the assist of three staff members, the patient was returned to bed in supine position.Patient was removed from the mattress overlay/frame set-up and placed onto a versacare bed.There was no injury to the patient.Follow up: the manufacturer followed up that their technician did not attach the mattress correctly to the bedframe.The manufacturer reported they will develop an action plan to prevent future similar occurrences.

• Brand Name: ENVISION THERAPEUTIC SURFACE OVERLAY MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): HILL-ROM INC; 1069 state route 46 east; j34; batesville, IN 47006
• MDR Report Key: 4286057
• MDR Text Key: 5295174
• Report Number: 4286057
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Model Number: E700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2014
• Patient Sequence Number: 1
• Treatment: FACILITY-OWNED BEDFRAME = ADVANTA
• Patient Age: 36 YR
• Patient Weight: 110