VERION DIGITAL MARKER M

Additional Manufacturer Narrative

INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED EXCESSIVE HEAT AT RIGHT SIDE BEHIND SCREEN OF MONITOR WAS NOTED. REPORTER INDICATED THAT THE TECHNICIAN HAD BURNED HER FINGER WHEN USING THE DIGITAL MARKER DEVICE. IT WAS NOT REPORTED AS TO THE SEVERITY OF THE INJURY. UPON ADDITIONAL FOLLOW UP, THE REPORTER INDICATED THE TECHNICIAN HAD MINOR REDNESS TO FINGER, AND BASICALLY SHE HAD SNATCHED HER HAND BACK FROM SOURCE OF HOT PLASTIC.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. DURING THE FIELD SERVICE ENGINEER (FSE) ON-SITE VISIT, THE REPORTED INJURY COULD NOT BE CONFIRMED.THE DEVICE WAS TESTED AND THE EXTREME HEAT COULD NOT BE REPRODUCED. THE DEVICE WAS REPLACED AS A PRE-CAUTIONARY MEASURE. EVALUATION REGARDING TEMPERATURE DISTRIBUTION ON THE BACKSIDE OF THE DEVICE WERE REVIEWED. A MAXIMUM TEMPERATURE OF 50.4°C HAS BEEN MEASURED ON THE SAME PRODUCT TYPE, AND A WARNING STICKER IS PLACED AT THE HOT LOCATION. HOWEVER A DESCRIPTION AND RESPECTIVE WARNING IS NOT AVAILABLE IN THE USER MANUAL. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADD WARNING INFORMATION TO THE USER MANUAL. (B)(4)

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER STATES BASIC FIRST AID TREATMENT APPLIED TO FINGER.