FDA Adverse Event Other Summary report: N

ENCORE

MDR report key: 453035 · Received April 4, 2003

Report

Report Number
453035
Event Type
Other
Date Received
April 4, 2003
Date of Event
April 1, 2002
Report Date
August 1, 2002
Manufacturer
ARJO, INC.
Product Code
FSA
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

TITLE: PT LIFT 1. THE FACILITY STARTED USING A NEW MECHANICAL LIFT CALLED THE ENCORE TO ASSIST PTS WITH STANDING AND TRANSFERRING. THE LIFT INVOLVES PARTIAL WEIGHT-BEARING BY THE PT WHO STANDS AGAINST THE DEVICE AND HOLDS ONTO GRIP HANDLES DURING THE TRANSFER. IT WAS NOTED THAT THE PT INVOLVED DEVELOPED BRUISES ON BOTH SHINS FROM THE PLASTIC PADS THAT REST AGAINST THE FRONT OF THE LEG BETWEEN THE KNEE AND THE ANKLE. THE SITE CONTACTED THE MFR ABOUT THIS PROBLEM WHO RECOMMENDED THAT THE FACILITY PURCHASE SHEEPSKIN PADS THAT THEY SUPPLY. THERE WAS NO MENTION BY THE MFR THAT THE SHEEPSKIN PADDING WAS AVIALABLE DURING THE TIME THAT STAFF TRAINING OCCURRED ON THE DEVICE. THERE WERE THREE PTS INVOLVED IN THIS INCIDENT, ALL ON THE SAME DAY. PT BRUISING SUBSIDED WITH THE USE OF PADS. IT IS BELIEVED THE WEIGHT BEARING STATUS AND PHYSICAL ABILITY OF THE PT DOES IMPACT THE DEGREE OF INJURY. THE COMPANY SALES REPRESENTATIVE PROVIDED TRAINING TO THE STAFF. THE DEVICE WAS BEING USED IN THE FACILITY WHERE THE STAFF HAVE BEEN INSERVICED ON THE USE OF THIS DEVICE. PTS CONTINUE TO USE THE LIFTS. THE SHEEPSKIN PADS WERE PURCHASED BY THE FACILITY. OTHER EQUIPMENT THAT MIGHT PREVENT FUTURE OCCURENCES: ADD PADDING AS STANDARD WITH NEW EQUIPMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENCORE PATIENT LIFT FSA ARJO, INC. KKA5020 *

Patients

Seq Age Sex Outcome Treatment
1 * Other