inforMED
OtherILE

ARMBOARD

Received Jul 17, 2007

Report 2921578-2007-00005 · MDR key 883670

Device

Generic name

Armboard

Manufacturer

Unk

Product problems

  • Component(s), worn
  • Component Incompatible
  • Use of Device Problem
  • Device Damaged Prior to Use

Patient

YR

  • Bone Fracture(s)

Narrative

Description of Event or Problem

ACCORDING TO THE OSI SALES REPRESENTATIVE CONVERSATION WITH THE HOSPITAL, THE HOSPITAL HAD BEEN USING AN OLDER IMAGING TOP WITH ANOTHER MEDICAL COMPANY'S ARMBOARDS WITHOUT THE SUGGESTED MIZUHO ORTHOPEDIC SYSTEMS SIDE RAIL ADAPTER. THE ARMBOARDS ATTACHMENT CLAMPS WAS ALSO WORN. THE USE OF THE DEVICE CAUSED THE CARBON SIDE RAILS TO BECOME DAMAGED. THE PATIENTS ARM MOVED PAST THE WORN DEVICES AND CAUSED THE PATIENTS HUMEROUS TO BECOME BROKEN.

Additional Manufacturer Narrative

CUSTOMER WAS REQUESTED TO PURCHASE THE CORRECT SIDE RAIL ADAPTER (5855-830) AND WAS REQUESTED TO PERFORM REGULAR MAINTENANCE ON PRODUCT BEFORE EACH USE. THE SIDE RAIL ADAPTER WAS PURCHASED.