FDA Adverse Event
Malfunction
Summary report: N
VIVIDIMAGE D HD
MDR report key: 25008506
·
Received April 27, 2026
Report
- Report Number
- 3008776287-2026-00128
- Event Type
- Malfunction
- Date Received
- April 27, 2026
- Date of Event
- November 29, 2023
- Report Date
- April 27, 2026
- Manufacturer
- BLACK DIAMOND VIDEO, INC.
- Product Code
- KQM
- UDI-DI
- 00724995195069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE VIVIDIMAGE D HD SURGICAL DISPLAY AND FOUND THAT THE POWER DISTRIBUTION BOARD WAS NOT WORKING PROPERLY. THE TECHNICIAN ADJUSTED THE POWER DISTRIBUTION BOARD, TESTED THE FUNCTION AND OPERATION OF THE UNIT, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE D HD SURGICAL DISPLAY MONITOR WAS FLICKERING. NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54735 | VIVIDIMAGE D HD | SURGICAL DISPLAY | KQM | BLACK DIAMOND VIDEO, INC. | RLM27HD2 | 00724995195069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |