BD FACSCANTO¿ II FLOW CYTOMETER
Received Sep 12, 2024 · Event occurred Sep 3, 2024
Report 2916837-2024-00046 · MDR key 20201704
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338960
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER THE CUSTOMER GOT ELECTRICAL SHOCK. NO INJURY OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ELECTRICAL SHOCK FROM TOP OF CARROUSEL. NO INJURY TO PATIENT. INSTRUMENT SHUT OFF AND ISOLATED.
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ELECTRICAL SHOCK FROM TOP OF CAROUSEL WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: COMPLAINT HISTORY REVIEW, SERVICE HISTORY REVIEW, RISK REVIEW. THE POTENTIAL CAUSE WAS NOT DETERMINED; HOWEVER, THE FIELD SERVICE ENGINEER INSPECTED THE POWER CORD CONNECTION AND GROUNDING OF THE OVERALL CYTOMETER AND FOUND NO DAMAGE. THE FSE ALSO CLEANED AND REINSTALLED THE MAIN LOADER CABLE CONNECTOR AND TESTED THE INSTRUMENT CONFIRMING EVERYTHING PASSED WAS WORKING WITHIN SPECIFICATION. THE CUSTOMER NOTED THERE WERE NO BURNS OR INJURY AS A RESULT OF THE ISSUE.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER THE CUSTOMER GOT ELECTRICAL SHOCK. NO INJURY OR TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ELECTRICAL SHOCK FROM TOP OF CARROUSEL. NO INJURY TO PATIENT. INSTRUMENT SHUT OFF AND ISOLATED.