MalfunctionJAF
ELITE PROBE
Received Jun 21, 2017 · Event occurred May 16, 2017
Report 3010611950-2017-00028 · MDR key 6656762
Device
Generic name
Elite 3mhz Probe
Manufacturer
Natus Neurology, IncorporatedModel number
X1L001Catalog number
N300
Lot number
N/A
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
0 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). BASED ON RISK ASSESSMENT CONDUCTED MAY 25, 2017, IT WAS DETERMINED THAT THERE IS A RISK OF INJURY IF THE MALFUNCTION WERE TO RECUR. THERE HAVE BEEN NO REPORTED INJURIES. REFERENCE FIELD CORRECTIVE ACTION NUMBER: 3010611950/06/09/2017/001-R.
Description of Event or Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Remedial action
- Recall