inforMED
MalfunctionILZ

OFFEST DOUBLE CLAMP

Received Mar 3, 2008 · Event occurred Feb 28, 2008

Report 1016489 · MDR key 1016489

Device

Generic name

Trapeze, Hospital Bed

Model number

00-1238-004-00

Catalog number

00-1238-004-00

Lot number

*

Product problems

  • Component(s), broken
  • Component Falling
  • Design/structure problem

Patient

*

  • Swelling
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

THE PATIENT WAS ON HER BED BEING TRANSPORTED TO THE OR. AS THE TRANSPORTER WAS PUSHING THE BED INTO THE HALL, THE BED WENT OVER A BUMP IN THE FLOOR WHERE CARPET MET HARD FLOORING. THE TRAPEZE BOLT HANGING ABOVE THE PATIENT SHEARED OFF AND THE TRIANGULAR PART OF THE TRAPEZE FELL ON THE PATIENT'S HEAD. THE TRAPEZE IS AN ORTHO DEVICE ATTACHED TO AN OVERHEAD BAR AT THE HEAD OF THE BED. THIS TRIANGULAR BAR FELL ON THE PATIENT'S HEAD. IT WAS DESCRIBED AS A 'KNOT' ON THE PATIENT'S HEAD AND ICE WAS APPLIED. THERE WERE NO DEFICITS NOTED. THE PATIENT PROCEEDED TO THE OR, COMPLETED THE SURGERY SATISFACTORILY. IT APPEARS THAT THE MANUFACTURER HAS MADE A DESIGN CHANGE AT SOME POINT BUT THE PART NUMBER HAS REMAINED THE SAME. THE PART REPORTED IN THIS EVENT IS FROM THE OLD DESIGN. IN THE NEW DESIGN THE BOLT APPEARS TO BE THICKER AND WIDER.