FDA Adverse Event
Malfunction
Summary report: N
NPI 200
MDR report key: 6913426
·
Received October 4, 2017
Report
- Report Number
- 6913426
- Event Type
- Malfunction
- Date Received
- October 4, 2017
- Date of Event
- January 1, 2017
- Report Date
- September 29, 2017
- Manufacturer
- NEUROPTICS INC.
- Product Code
- HLG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694005 | NPI 200 | PUPILLOMETER, AC-POWERED | HLG | NEUROPTICS INC. | 17-1494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |