VIVIDIMAGE 4K
Report
- Report Number
- 3008776287-2023-00007
- Event Type
- Malfunction
- Date Received
- July 20, 2023
- Date of Event
- April 26, 2023
- Report Date
- July 20, 2023
- Manufacturer
- BLACK DIAMOND VIDEO, INC.
- Product Code
- KQM
- UDI-DI
- 00724995195113
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
STERIS SERVICE AND ENGINEERING ARE ACTIVELY WORKING WITH THE CUSTOMER ONSITE AND WITH REMOTE ACCESS TO TRY AND DETERMINE THE ROOT CAUSE OF THE ISSUE. DATA LOGS WERE COLLECTED FROM THE RECENT INVESTIGATION ACTIVITIES PERFORMED AT THE USER FACILITY. THE DATA LOGS ARE CURRENTLY BEING ANALYZED BY STERIS ENGINEERING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.
DURING OUR ONSITE VISIT AT THE USER FACILITY IN APRIL 2024, THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE DATA LOGS WERE REVIEWED AND NO ISSUES WERE NOTED. THE REVIEW OF THE ROOMS AT THE FACILITY CONFIRMED THAT THE CABLING AND VOLTAGES ARE CORRECT. STERIS HAS PROPOSED A PLAN WITH THE CUSTOMER AND ORDERED PARTS TO INSTALL TO MONITOR AND ADDRESS THIS ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
STERIS HAS BEEN WORKING WITH THE CUSTOMER TO RESOLVE THIS REPORTED ISSUE. PRIOR TO THIS REPORTED EVENT ON (B)(6) 2023, STERIS HAD A MEETING WITH THE CUSTOMER ON (B)(6) 2023 TO FURTHER INVESTIGATE THE ISSUE. DURING TESTING, A STERIS SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT WHEN THE CAMERA WAS ROUTED THROUGH THE VUCAPTURE CARD. STERIS SCHEDULED THE REPLACEMENT OF THE VUCAPTURE CARD WITH THE CUSTOMER ON (B)(6) 2023. THE VUCAPTURE CARD WAS REPLACED, THE SYSTEM WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. FOLLOWING THE REPAIRS DURING TESTING, THE ISSUE COULD NOT BE DUPLICATED. FOLLOWING THE REPLACEMENT OF THE VUCAPTURE CARD, THE EVENT SUBJECT OF THIS REPORT OCCURRED ON (B)(6) 2023. THE STERIS TECHNICIAN ARRIVED ONSITE TO TROUBLESHOOT THE ISSUE AND INSTALLED A NEW POWER SUPPLY. THE TECHNICIAN TESTED THE UNIT AND FOUND IT TO BE OPERATING PROPERLY; THE EVENT COULD NOT BE DUPLICATED. THE UNIT WAS RETURNED TO SERVICE. DUE TO THE RECURRENCE OF THE REPORTED ISSUE, THE UNIT WILL BE RETURNED TO STERIS FOR EVALUATION. THE USER FACILITY WILL BE PROVIDED WITH A LOANER UNIT. STERIS IS COORDINATING THE REPLACEMENT OF THE UNIT WITH THE USER FACILITY.
STERIS SCHEDULED AN ONSITE VISIT BASED ON THE CUSTOMER'S AVAILABILITY TO INVESTIGATE THE REPORTED ISSUE FOR THE WEEK OF (B)(6) 2024. A STERIS SERVICE ENGINEER AND TECHNICIAN ARE CURRENTLY ONSITE AT THE USER FACILITY AND ARE ACTIVELY WORKING TO TROUBLESHOOT AND RESOLVE THE ISSUE WITH THE DISPLAY ON THEIR SYSTEM. OUR INVESTIGATION INTO THE ROOT CAUSE OF REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
A LOANER UNIT WAS INSTALLED AT THE USER FACILITY AND THE REPLACEMENT UNIT IS BEING RETURNED TO STERIS. STERIS RECENTLY BECAME AWARE THAT THE CUSTOMER EXPERIENCED THE SAME ISSUE WITH THE IMAGE CUTTING OUT ON THE MONITOR WITH THE NEWLY INSTALLED LOANER UNIT. THIS OCCURRED SHORTLY AFTER INSTALLATION AND WAS NOT REPORTED TO HAVE OCCURRED DURING A PATIENT PROCEDURE. AS A RESULT, OUR INVESTIGATION WILL BE REFOCUSING ON EVALUATING THE ISSUE AT THE CUSTOMER FACILITY RATHER THAN THE EVALUATION OF THE RETURNED UNIT. STERIS SERVICE AND ENGINEERING ARE ACTIVELY WORKING WITH THE CUSTOMER ONSITE AND WITH REMOTE ACCESS TO TRY AND DETERMINE THE ROOT CAUSE OF THE ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.
IN 2024 AS ANOTHER SOLUTION TO MITIGATE THE ISSUE, AN EDID MINDER WAS INSTALLED IN OR8. THE EDID MINDER MONITORS THE DISPLAY AND COMBINES THE DISPLAY DATA WITH ITS INTERNAL EDID TABLE TO SEND BACK TO THE HIQ SYSTEM ALLOWING FOR MOST STABLE COMMUNICATION BETWEEN THE RECEIVE MODEM AND THE DISPLAY. DURING THIS VISIT, STERIS WITH THE SUPPORT OF THE SOFTWARE DEVELOPER ATTEMPTED TO RECREATE THE PROBLEM. THE OR WAS AVAILABLE FOR ONE HOUR AND WE WERE UNABLE TO RECREATE THE ISSUE. SINCE INSTALLATION OF THE EDID MINDER, THERE HAVE BEEN NO ISSUES REPORTED TO STERIS BY THE CUSTOMER IN THIS OR. STERIS WILL INSTALL AND UTILIZE MONITORING EQUIPMENT IN OR6 AND OR8 TO SEE IF THE ISSUE RECURS AND DETERMINE A ROOT CAUSE. IF THE ISSUE DOES NOT RECUR IN OR6 AND OR8 AND FURTHER TESTING IS INCONCLUSIVE, THEN SIMILAR HARDWARE TO THE EDID MINDER MAY BE INSTALLED IN THE REMAINING ORS. STERIS WILL COMPLETE ANOTHER ONSITE EXTENSIVE TROUBLESHOOTING SESSION TO ATTEMPT TO RECREATE THE ISSUE IN ONE OF THE REMAINING ORS THE WEEK OF SEPTEMBER 16 AND COLLECT DATA TO DETERMINE ROOT CAUSE.
ON SEPTEMBER 16-19, 2024, STERIS SERVICE AND ENGINEERING ARRIVED ONSITE TO PERFORM TESTING THROUGHOUT THE WEEK IN THE EVENING WHILE THE ORS WERE AVAILABLE. THE BLINKING ISSUE WAS DUPLICATED ONLY WHILE ROUTING A STORZ CAMERA (50 HZ VIDEO) THROUGH THE CAPTURE CARD. ADDITIONAL TESTING WAS PERFORMED TO VERIFY THE ISSUE WAS ONLY PRESENT WITH 50HZ VIDEO THROUGH THE CAPTURE CARD. TO RESOLVE THE ISSUE, A LIMA SCALER WAS INSTALLED. THE LIMA SCALER CONVERTS THE 50HZ TIMING FROM THE STORZ CAMERA TO 60HZ TO BE COMPATIBLE WITH THE CAPTURE CARD. ADDITIONAL TESTING AND MONITORING WERE PERFORMED FOLLOWING INSTALLATION OF THE LIMA SCALER TO ENSURE THAT THE INTERMITTENT ISSUE DID NOT RECUR. BASED ON THE RESULTS OF OUR IN-DEPTH ONSITE INSPECTION, THE ISSUE IS RELATED TO HOW THE CAPTURE CARD HANDLED THE 50HZ VIDEO. ADDITIONAL EQUIPMENT (LIMA SCALERS) WILL BE INSTALLED ON ANY 50HZ VIDEO SOURCES WHICH CANNOT BE CHANGED TO 60HZ. STERIS WILL CONTINUE TO MONITOR TO ENSURE THAT THE ISSUE DOES NOT RECUR FOLLOWING INSTALLATION OF THE LIMA SCALERS.
THE LIMA SCALERS HAVE BEEN INSTALLED AT THE FACILITY WHERE APPROPRIATE. STERIS HAS CONTINUED TO MONITOR THE PERFORMANCE OF THE DEVICES WITH THE CUSTOMER SINCE THE INSTALLATION OF THE LIMA SCALERS. TO DATE, THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE WITH THE LIMA SCALERS INSTALLED. AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN AS NO ADDITIONAL ISSUES HAVE BEEN REPORTED. STERIS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.
ON APRIL 26, 2023, THE USER FACILITY NOTIFIED STERIS THAT DURING A PATIENT PROCEDURE THE IMAGE ON THE VIVIDIMAGE 4K SURGICAL DISPLAY WAS CUTTING OUT. NO REPORT OF INJURY. STERIS INITIALLY REPORTED THIS EVENT IN MDR # 3008776287-2023-00002-02 ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910886 | VIVIDIMAGE 4K | SURGICAL DISPLAY | KQM | BLACK DIAMOND VIDEO, INC. | RLM314K3 | 00724995195113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |