FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 12257133
·
Received July 31, 2021
Report
- Report Number
- 9610877-2021-10515
- Event Type
- Malfunction
- Date Received
- July 31, 2021
- Date of Event
- February 26, 2021
- Report Date
- July 31, 2021
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- PEA
- UDI-DI
- 04961333232918
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I5500C IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. EVALUATION SUMMARY IT WAS CAUSED DUE TO THE CPU BOARD FAILURE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.
Description of Event or Problem · 1
THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ERROR ON THE DISPLAY : AN ERROR OCCURRED DURING INITIALIZATION OF PATIENT DATABASE; SYSTEM ERROR 002-0006.(PATIENT_DATABASE_ERROR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1154304 | PENTAX | IMAGINA PROCESSOR (INCLUDES I-SCAN)-INT | PEA | HOYA CORPORATION PENTAX TOKYO OFFICE | EPK-I5500C | 04961333232918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |