HOYER PRESENCE LIFT

Additional Manufacturer Narrative

THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

Description of Event or Problem

IT WAS REPORTED TO THE MANUFACTURER BY THE END USER: AT APPROXIMATELY 11AM, RESIDENT SUSTAINED TWO SKIN TEARS TO THE RIGHT ARM AND ONE SKIN TEAR TO THE RIGHT SHIN DURING A TRANSFER FROM BED TO WHEELCHAIR VIA THE HOYER LIFT. DURING THE TRANSFER, THE RESIDENT BEGAN TO LEAN TO THE LEFT AND SLIP OUT OF THE HOYER PAD. STAFF IMMEDIATELY RE-POSITIONED THE RESIDENT SAFELY BACK OVER THE BED AND LOWERED HER BACK INTO THE BED. DURING THE INCIDENT, THE RESIDENT BUMPED HER LEFT SHOULDER ON THE HOYER LIFT MACHINE AND COMPLAINED OF PAIN TO THE AREA. SKIN TEARS TO THE RIGHT ARM AND SHIN ASSESSED; AREAS CLEANSED AND DRESSED. LEFT SHOULDER ASSESSED FOR ROM; NO DEFORMITY NOTED AND CIRCULATION INTACT. PATIENT WAS THEN TRANSFERRED VIA HOYER TO HER WHEELCHAIR PER HER REQUEST FOR LUNCH. NO COMPLAINTS OF PAIN AT THAT TIME. PATIENT WORKED WITH THERAPY FOR APPROXIMATELY 30 MINUTES AT 11:50AM PERFORMING HIP FLEXION EXERCISES. PATIENT WAS TRANSFERRED BACK TO BED VIA HOYER LIFT AT APPROX. 1:45PM. NURSE NOTICED SOME NOTED SWELLING IN RIGHT UPPER THIGH. SPOKE WITH PHYSICIAN, ORDER TO SEND TO ER FOR EVALUATION.