MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-05 for NICOLET VERSALAB LE XVLB02 manufactured by Natus Neurology, Incorporated.
[96581360]
(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.
Patient Sequence No: 1, Text Type: N, H10
[96581361]
Abi reading normal. Patient sent to specialist and arterial disease was diagnosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2017-00048 |
| MDR Report Key | 7169845 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-05 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-11-21 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2018-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JANESSA BOONE |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298603 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET VERSALAB LE |
| Generic Name | NICOLET VERSALAB |
| Product Code | JAF |
| Date Received | 2018-01-05 |
| Model Number | XVLB02 |
| Catalog Number | XVLB02 |
| Lot Number | N/A |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-05 |