SYSTEM 2000

Description of Event or Problem

REF IMP REPORT NUMBER: (B)(4).

Additional Manufacturer Narrative

(B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR SYSTEM 2000 WE HAVE FOUND A LOW NUMBER OF OTHER SIMILAR CASES - UNCOMMANDED DOWN MOVEMENT OF THE BATH. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND CONCERNING THESE KIND OF EVENTS. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) BATHS TO DATE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REP AT THE CUSTOMER SITE AND FOUND TO BE TO THE SPEC. THE DEVICE WAS BEING USED FOR PT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM THE INFO RECEIVED CAREGIVER CRUSHED MUSCLE TO LEFT FOOT LITTLE TOE AREA. X-RAY PROVED NO BROKEN BONES. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. FROM ABOVE FINDINGS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED BY USER ERROR - USER NOT CORRECTLY TRAINED. THE CAREGIVER DID NOT FOLLOW WARNINGS INCLUDED IN IFU - TUB WAS LOWERED ONTO OBSTRUCTION - LIFT'S ACTUATOR.