MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-04 for NPI 200 manufactured by Neuroptics Inc..
[88157638]
Patient Sequence No: 1, Text Type: N, H10
[88157639]
Device type: pupillometer, manufacturer: neuroptics inc. , model: npi 200 charger. Charger docking station has a design problem. The charger keeps burning out within 60 days of operation. We currently have 41 pupillometers in our facility and we have replaced 50% of our chargers. The manufacturer is aware of the problem and has been replacing the defective chargers with new and improved versions. However, they are not replacing the chargers that are currently working even though they know that they have a problem. Manufacturer response for pupillometer, (brand not provided) (per site reporter): we are currently working with the sales representative. However, we don't have a solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6913426 |
| MDR Report Key | 6913426 |
| Date Received | 2017-10-04 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-01-01 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-10-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NPI 200 |
| Generic Name | PUPILLOMETER, AC-POWERED |
| Product Code | HLG |
| Date Received | 2017-10-04 |
| Returned To Mfg | 2017-09-21 |
| Lot Number | 17-1494 |
| ID Number | NPI2-CHG-01 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROPTICS INC. |
| Manufacturer Address | 18101 VON KARMAN AVE STE 1940 IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-04 |