FDA Adverse Event
Malfunction
Summary report: N
HIGH DEFINITION LCD MONITOR
MDR report key: 10255828
·
Received July 9, 2020
Report
- Report Number
- 8010047-2020-04083
- Event Type
- Malfunction
- Date Received
- July 9, 2020
- Date of Event
- May 15, 2020
- Report Date
- July 10, 2020
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FET
- PMA / PMN Number
- K102379
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. EVALUATION HAS CONFIRMED THE FOLLOWING; -PROSOUND F75 DID NOT OUTPUT THE SIGNAL THAT WAS THE INPUT DETECTION CONDITION FOR THE SUBJECT DEVICE. THEREFORE, THE SUBJECT DEVICE COULD NOT DETECT THE INPUT AND THE REPORTED EVENT OCCURRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem · 1
DURING AN UNSPECIFIED PROCEDURE WITH THE SUBJECT DEVICE AND A HITACHI, LTD. DIAGNOSTIC ULTRASOUND SYSTEM, PROSOUND F75, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719229 | HIGH DEFINITION LCD MONITOR | HIGH DEFINITION LCD MONITOR | FET | OLYMPUS MEDICAL SYSTEMS CORP. | OEV262H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |