MIDMARK
Received Jun 4, 2015 · Event occurred May 4, 2015
Report 1523530-2015-00004 · MDR key 4828022
Device
Product problems
- Defective Device
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CLINICIAN USER GRABBED THE HANDLE TO MOVE THE LIGHT WHEN THE BULB CRACKED. A PIECE OF THE BULB LANDED ON THE CLINICIAN'S GOWN. NO MEDICAL ATTENTION REQUIRED.
Additional Manufacturer Narrative
VOLTAGE TESTING PERFORMED AS EXPECTED. NO PERFORMANCE ISSUES WERE IDENTIFIED. THE UNIT WAS NOT RETURNED TO MIDMARK FOR ASSESSMENT. THIS PRODUCT IS NO LONGER MANUFACTURED BY MIDMARK. THERE IS NO HISTORY OF SIMILAR EVENT. UNABLE TO CONFIRM CAUSE OF THE FAILURE.