MAUDE MDR 4017670

MDR report key
4017670
Report number
3005536958-2014-00009
Event key
0
Event type
3
Date of event
2014-07-18
Date received
2014-08-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
344 NORTH READING RD. EPHRATA PA 17522 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MINILIFT200HANDICARE ABFMR200401100334* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-1201. H

Event Narratives#

D

Patient 1

A FACILITY STAFF MEMBER WAS TRANSFERRING THE RESIDENT FROM A WHEELCHAIR TO A BED USING THE MINI LIFT 200. DURING THE TRANSFER, THE LIFT TIPPED, THE RESIDENT SUFFERED A C-6 FRACTURE AND LEFT HIP FRACTURE. A HANDICARE REP VISITED THE FACILITY TO ASSESS THE INCIDENT. AFTER ASSESSING THE STAFF MEMBER'S STATEMENT, AN ATTEMPT WAS MADE TO RE-CREATE THE INCIDENT AS DESCRIBED BY THE STAFF MEMBER. WHEN THE LIFT WAS POSITIONED BY THE BED, THE BASE OF THE LIFT WAS APPROXIMATELY 6-8" UNDER THE BED FRAME, MAKING IT IMPOSSIBLE TO TIP FROM THIS POSITION. THE HANDICARE REP THEN TRIED A 'WORST CASE SCENARIO', ATTEMPTING TO TIP THE LIFT AWAY FROM THE BED AND WITH THE CASTOR'S LOCKED AND WAS STILL UNABLE TO CAUSE THE UNIT TO TIP. IT WAS NOTED THAT THERE WAS DAMAGE TO THE LIFT WHICH WAS INCONSISTENT WITH THE INCIDENT DESCRIBED BY THE STAFF MEMBER OPERATING THE LIFT. THE UNIT WAS FULLY INSPECTED AND TESTED BY THE HANDICARE REP AND DEEMED FIT FOR USE. BASED ON THE INFO SUPPLIED, HANDICARE FEEL THAT THE INCIDENT OCCURRED DUE TO THE EQUIPMENT BEING USED IN A WAY NOT ADVISED OR DESCRIBED IN THE USER MANUAL. BY FOLLOWING THE DIRECTIONS IN THE USER MANUAL, THE INCIDENT COULD NOT BE RE-CREATED. HANDICARE'S EVALUATION IS IMPROPER USE OF EQUIPMENT.