FDA Adverse Event Malfunction Summary report: N

TENOR

MDR report key: 3150025 · Received May 31, 2013

Report

Report Number
1419652-2013-00140
Event Type
Malfunction
Date Received
May 31, 2013
Date of Event
May 4, 2013
Report Date
May 6, 2013
Manufacturer
ARJOHUNTLEIGH POLSKA SP. ZO.O.
Product Code
FSA
Product Problem
Yes
Report Source
Distributor report
Reporter Location
KY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

INITIALLY REPORTED BY COMPANY REPRESENTATIVE: "TWO CAREGIVERS WERE IN ROOM TO TRANSFER RESIDENT FROM BED TO CHAIR. TENOR LIFT WAS PLACED OVER THE BED AND SLING UNDER RESIDENT. CAREGIVER LIFTED RESIDENT WITH TENOR LIFT OFF BED. ROLLED LIFT BACK WITH RESIDENT ABOUT THREE FEET, STOPPED, CLOSED LEGS ON TENOR LIFT TO PREPARE TO TURN LIFT TO CHAIR. AT THIS POINT A SNAP WAS HEARD AND RESIDENT, SLING, AND SPREADER BAR FELL TO THE FLOOR, ABOUT THREE FEET. RESIDENT LANDED ON LEFT SIDE AND SPREADER BAR LANDED ON RESIDENT'S RIGHT SIDE. ONE CAREGIVER LEFT ROOM TO GET STAFF NURSE WHILE OTHER CAREGIVER REMAINED IN ROOM WITH RESIDENT. NURSE REQUESTED AN AMBULANCE BE CALLED TO TRANSPORT TO ER. X-RAYS WERE DONE ON HIPS AND SHOULDERS. PATIENT HAD BRUISING, LEFT FOREARM HAD SKIN TEAR AND COMPLAINED OF BACK PLAN. NO OTHER INJURIES SEEN."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
241154 TENOR PASSIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. KHA1000-US

Patients

Seq Age Sex Outcome Treatment
1 51 YR Other