OtherGLK
BAYER ADVIA 120 SYSTEM
Received Oct 11, 2002 · Event occurred Sep 11, 2002
Report 2432235-2002-00007 · MDR key 421929
Device
Generic name
Hematology System
Manufacturer
Bayer Diagnostics Mfg. Ltd, Swords, Co.Model number
ADVIA 120Catalog number
254
Lot number
NA
Product problems
- Material Separation
Patient
51 YR
- Head Injury
- Headache
- Concussion
- Dizziness
Narrative
Description of Event or Problem
IN 02, PT WAS PERFORMING MAINTENANCE ON THE ADVIA 120 SYSTEM WITH THE UPPER LID OPEN TO ALLOW BETTER ACCESS TO THE CLOSED TUBE AREA. THE LID FELL ON PT'S HEAD. PT FELT DIZZY AND HAD HEAD PAIN. PT WENT HOME TO REST AND NAP. PT WENT TO EMPLOYEE HEALTH WHO HAVE REPORTED THAT PT WAS OK BUT MAY HAVE HAD A SLIGHT CONCUSSION. BAYER WAS NOTIFIED. BASED ON THE AVAILABLE DATA, BAYER'S MEDICAL DIRECTOR INDICATED THAT AN MDR SHOULD BE FILED.