inforMED
MalfunctionFSQ

TRULIGHT DUO

Received Aug 16, 2018 · Event occurred Jul 17, 2018

Report 9681407-2018-00039 · MDR key 7790301

Device

Generic name

Surgical Light

Model number

1574850

Product problems

  • Mechanical Problem
  • Detachment of Device or Device Component
  • Mechanical Problem
  • Detachment of Device or Device Component

Patient

Not reported

  • Injury
  • Injury

Narrative

Additional Manufacturer Narrative

THE ACCOUNT'S TECHNICIAN RECEIVED A REQUEST TO ADJUST THE LIGHT DUE TO A DRIFTING LIGHT HEAD. WHILE ADJUSTING THE LIGHT, THE SPRING ARM SEPARATED FROM THE CENTRAL AXIS, KNOCKING THE ACCOUNT'S TECHNICIAN FROM HIS LADDER TO THE FLOOR. THE LIGHT STRUCK HIM AND HE SUFFERED A LACERATION ABOVE HIS EYE THAT REQUIRED SIX STITCHES. HE ALSO STRUCK HIS HEAD ON THE FLOOR THEN UNDERWENT A CT SCAN AND X-RAY. HE WAS LATER DIAGNOSED WITH A CONCUSSION AND PLACED ON LIGHT DUTY RESTRICTION AT WORK. THE HILL-ROM FIELD SERVICE TECHNICIAN CONFIRMED THE NARRATIVE GIVEN BY THE ACCOUNT'S TECHNICIAN. HE FOUND THE FAILURE WAS LIKELY DUE TO THE IMPROPER INSTALLATION OF THE SNAP RING AT THE SPRING ARM - CENTRAL AXIS JOINT. THE SNAP RING WILL BE REPLACED ONCE THE REPLACEMENT PARTS ARRIVE.

Description of Event or Problem

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE SPRING ARM SEPARATED FROM THE CENTRAL AXIS, FELL AND STRUCK A FACILITY SERVICE TECHNICIAN. THE LIGHT WAS LOCATED AT THE ACCOUNT. THERE WAS A MODERATE INJURY REPORTED.

Remedial action

  • Repair