NICOLET VERSALAB LE
Received Jan 5, 2018 · Event occurred Nov 21, 2017
Report 3010611950-2017-00048 · MDR key 7169845
Device
Generic name
Nicolet Versalab
Manufacturer
Natus Neurology, IncorporatedModel number
XVLB02Catalog number
XVLB02
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
0 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). PATIENT COMPLAINED OF LEG PAIN. THE VERSALAB WAS THEN USED TO PERFORM AN ABI EXAM. THE RANGES WERE DETERMINED TO BE IN NORMAL RANGE. THE CUSTOMER SENT THE PATIENT TO A SPECIALIST WHERE ADDITIONAL TESTS WERE CONDUCTED. IT IS UNCLEAR WHAT ADDITIONAL TESTS WERE CONDUCTED. BASED ON THOSE RESULTS, STENTS WERE PLACED IN THE PATIENT'S LEGS. THE VERSALAB IS 10 YEARS OLD, PAST RECOMMENDED PRODUCT LIFE. THE CUSTOMER BELIEVES THE VERSALAB IS FUNCTIONING AS INTENDED AND ARE NOT INTERESTED IN PURCHASING A NEW SYSTEM, NOR ARE THEY ABLE TO RETURN THEIR DEVICE BECAUSE THEY ONLY HAVE ONE SYSTEM AND IT IS NEEDED TO CONDUCT ABIS.
Description of Event or Problem
ABI READING NORMAL. PATIENT SENT TO SPECIALIST AND ARTERIAL DISEASE WAS DIAGNOSED.