inforMED

OPTIMA 220R

Received Oct 29, 2012 · Event occurred Jul 31, 2012

Report 2839336 · MDR key 2839336

Device

Generic name

X-ray, Dr Cassette

Model number

MDL 5331287

Catalog number

*

Lot number

*

Product problems

  • Improper or Incorrect Procedure or Method
  • Manufacturing, Packaging or Shipping Problem

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHEN PLACING THE DR CASSETTE UNDER A PATIENT FOR CHEST OR ABDOMINAL X-RAY USING THE MANUFACTURER'S RECOMMENDED METHOD (HANDLE), THE IMAGING STAFF QUITE FREQUENTLY, INADVERTENTLY PRESSES THE POWER BUTTON LOCATED ON THE HANDLE OF THE DEVICE. THIS DELAYS THE PROCEDURE AS THE CASSETTE MUST BE POWERED BACK ON AND REINITIALIZED. OTHER METHODS OF INSERTING THE CASSETTE ARE AWKWARD AND REQUIRE TWO HANDS.PLACEMENT OF THE UNPROTECTED POWER SWITCH SHOULD BE RECONSIDERED.