inforMED
MalfunctionILM

MALIBU/SOVEREIGN (INCL. DIGNITY)

Received Aug 9, 2013 · Event occurred Jul 22, 2013

Report 1419652-2013-00223 · MDR key 3297433

Device

Product problems

  • Defective Component

Patient

85 YR

  • Abrasion
  • Head Injury

Narrative

Description of Event or Problem

IT WAS REPORTED TO ARJOHUNTLEIGH THAT THE RESIDENT WAS TAKING A BATH AND THE SAFETY BELT WAS SECURED AROUND THE RESIDENTS WAIST AND A NURSE WAS IN ATTENDANCE, THE SEAT WAS IN ITS LOWEST POSITION IN THE BATH WHEN THE RESIDENT SUDDENLY LURCHED FORWARD AND TRIED TO STAND UP. IT WAS SAID THAT THE SAFETY BELT DID NOT RETAIN THE RESIDENT AND HE FELL FORWARD BUMPING THE TOP OF HIS HEAD ON THE FOOT END OF THE BATH THUS SUSTAINING A SLIGHT SKIN ABRASION TO THE TOP OF THE HEAD. AN ARJOHUNTLEIGH TECHNICIAN VISITED SITE AND FOUND THE GENERAL CONDITION OF THE BATH TO BE VERY GOOD AND THAT IT FUNCTIONED CHECKED OK. REFERENCE MFR #: (B)(4).