inforMED
MalfunctionITH

TRACTION MACHINE - ME 4000

Received Jun 5, 2013 · Event occurred May 17, 2013

Report MW5030472 · MDR key 3161615

Device

Generic name

Mtd - Me 4000

Model number

ME 4000

Product problems

  • Break
  • Detachment Of Device Component
  • Device Slipped

Patient

58 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A PT WAS PLACED INTO A HARNESS FOR CERVICAL TRACTION. THE CABLE WAS PRETESTED FOR SLIPPING BY PT. THE CABLE WAS ATTACHED TO THE HARNESS BY THE PT. AS THE CABLE WAS ATTACHED, THERE WAS NO NOTED ABNORMALITY OR FRAYING OF THE CABLE. THE TRACTION PULL WAS INITIATED. WHEN THE PULL REACHED ABOUT 17 LBS ON THE DIGITAL READOUT, THE CABLE BROKE FROM THE CLIP. THE TRACTION HARNESS WAS DISENGAGED FROM THE MOTOR SUDDENLY. 140291-2013-8.