FDA Adverse Event Injury Summary report: N

MIRANTI

MDR report key: 3870165 · Received April 29, 2014

Report

Report Number
1419652-2014-00116
Event Type
Injury
Date Received
April 29, 2014
Date of Event
April 10, 2014
Report Date
April 10, 2014
Manufacturer
ARJO HUNTLEIGH POLSKA SP. Z.O.O.
Product Code
FSA
Adverse Event
Yes
Report Source
Distributor report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ARJOHUNTLEIGH HAS BEEN INITIALLY INFORMED ABOUT AN INCIDENT INVOLVING ONE OF ITS DEVICES: "PT HAD HAD A BATH USING THE HOIST, HE WAS HOISTED OUT OF THE BATH AND GOT OFF THE HOIST SO STAFF COULD ASSIST WITH DRYING THE PT, WHEN HE WAS DRIED AND HAD GOT PARTIALLY DRESSED T-SHIRT AND BOXERS AT THIS POINT THE PT SAT ON THE FOOT END OF THE STRETCHER AND AS THE WEIGHT WAS TRANSFERRED TO THE HOIST THE UNIT BECAME UNSTABLE AND FLIPPED ON TO ITS SIDE WITH THE PT LAYING ON HIS LEFT SIDE ON THE LEG AND MIDDLE SECTIONS OF THE HOIST, THE BACK REST SECTION HAD RELATED AND WAS RESTING ON TOP OF THE PT. THE BACK REST WAS LIFTED OUT OF THE WAY AND THE PT WAS CAREFULLY SLID SIDE WAYS FROM THE HOIST WHICH WAS THEN REMOVED TO ALLOW A MOBILE SLING LIFTER TO BE USED TO LIFT THE PT INTO A WHEEL CHAIR AND THEN ONTO HIS BED". REF MFR # 3007420694-2014-00053.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
256173 MIRANTI FSA ARJO HUNTLEIGH POLSKA SP. Z.O.O.

Patients

Seq Age Sex Outcome Treatment
1 Other