inforMED
MalfunctionLMC

8900 DRYVIEW LASER

Received Sep 29, 2014 · Event occurred Sep 12, 2014

Report 2134259-2014-00016 · MDR key 4156087

Device

Generic name

8900 Dryview Laser Imager

Model number

8900

Catalog number

1780774

Product problems

  • Electronic Property Issue

Patient

NA

  • No Patient Involvement

Narrative

Description of Event or Problem

CUSTOMER REPORTED A BURNING ODOR COMING FROM THE UNIT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO CARESTREAM. A ROOT CAUSE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED. A FOLLOW UP REPORT WILL BE SUBMITTED. THE SITE AT WHICH THE UNIT WAS MANUFACTURED IS NOW CLOSED AND THIS PRODUCT IS NO LONGER MANUFACTURED.