inforMED
MalfunctionILM

MALIBU/SOVEREIGN (INCL. DIGNITY)

Received Jun 30, 2014 · Event occurred May 30, 2014

Report 1419652-2014-00170 · MDR key 3939020

Device

Product problems

  • Detachment Of Device Component
  • Component Falling

Patient

73 YR

  • Fall
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

INITIALLY IT WAS REPORTED BY ARJOHUNTLEIGH REPRESENTATIVE THAT THE PATIENT WAS READY TO BE BATHED, THE SEAT WAS SWUNG OUT OF THE BATH READY FOR THE PATIENT TO SIT ON. THE PATIENT APPROACHED THE SEAT FROM THE LEFT HAND SIDE AND AS SHE SAT DOWN AND STARTED TO SLIDE ONTO THE SEAT, THE MOULDING BECAME DETACHED MOVING TO THE RIGHT AND THE MOULDING AND THE PATIENT FELL TO THE FLOOR. NO INJURY OCCURRED TO THE PATIENT OR CAREGIVER ASA RESULT OF THIS INCIDENT. REF MFR # 9611530-2014-00042.