MALIBU/SOVEREIGN (INCT. DIGNITY)
Received Feb 23, 2015 · Event occurred Feb 4, 2015
Report 3007420694-2015-00039 · MDR key 4541650
Device
Manufacturer
Arjo Huntleigh Equipment AbModel number
AUR1135-GBProduct problems
- Component Incompatible
Patient
Not reported
- Fall
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO HUNTLEIGH (B)(4). AS OF 2014 THAT NUMBER WAS DEACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
Description of Event or Problem
INITIAL I WAS REPORTED BY ARJOHUNTLEIGH REP THAT THE PT FELL OF HOLST. AS A RESULT OF THIS INCIDENT, PT FRACTURED PELVIS AND RIGHT HUMERUS (ARM). IT IS NOT POSSIBLE TO OBTAIN MORE INFO AS STAFF REFUSED TO EXPLAIN DESCRIPTION OF EVENTS. DEVICE CONDITION HAS BEEN DESCRIBED AS SATISFACTORY. FUNCTION TEST SHOWED THAT EVERYTHING WORKING OK. IT WAS STATED THAT INCORRECT SAFETY BELT WAS FITTED. THERE ARE NO RECORDS OF THIS BEING FITTED BY ARJOHUNTLEIGH. REF IMP # (B)(4).