MDRC-1119 WITH PROTECTIVE COVER KIT
Received Feb 27, 2017
Report 9613188-2017-00002 · MDR key 6359988
Device
Generic name
Clinical Review Display
Manufacturer
Barco NvModel number
MDRC-1119 PROTECTIVE COVER KITCatalog number
C9826109
Lot number
N/A
Product problems
- Detachment Of Device Component
- Improper or Incorrect Procedure or Method
- Detachment Of Device Component
- Improper or Incorrect Procedure or Method
Patient
0 HR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE DISPLAY NOR ITS FRONT COVER WERE RETURNED TO THE MANUFACTURER. HOWEVER BASED ON PHOTOGRAPHS AND OTHER INFORMATION FROM THE CUSTOMER AND IN-HOUSE TESTING IT WAS CONCLUDED THAT THE METAL STRIPS THAT ARE APPLIED (GLUED) TO THE DISPLAY FOR FIXATION OF THE COVER, WERE CLEARLY RE-USED. AS A RESULT THE STRIPS ARE NOT FLAT BUT BENDED, RESULTING IN A DECREASED CONTACT SURFACE WITH THE FRONT COVER. IT IS OBVIOUSLY NOT THE INTENTION TO RE-USE THE FIXATION STRIPS BUT THIS WAS NOT SPECIFICALLY INDICATED IN THE INSTALLATION INSTRUCTIONS. A SPECIFIC WARNING WILL BE ADDED IN THE INSTALLATION INSTRUCTIONS.
Description of Event or Problem
DURING USAGE OF THE SYSTEM, THE FRONT COVER DETACHED FROM THE DISPLAY AND HIT THE PATIENT ON THE CHEEK. A MODERATE INJURY WAS REPORTED.
Remedial action
- Relabeling