CIRRUS HD-OCT 6000
Received Apr 4, 2023 · Event occurred Mar 16, 2023
Report 2918630-2023-00001 · MDR key 16678757
Device
Generic name
Cirrus Hd-oct
Manufacturer
Carl Zeiss Meditec, Inc.Model number
6000Catalog number
266002-1173-109
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2023, CZMI BECAME AWARE THAT ON (B)(6) 2023, A USER IN GERMANY HAD RECEIVED AN ALLEGED ELECTRIC SHOCK WHILE OPERATING THE CIRRUS 6000 POWER TABLE. IT WAS COMMUNICATED THAT UPON RECEIVING THE SHOCK, THE USER BRIEFLY HAD A PAIN IN HER FINGER AND FOR THE REST OF THE DAY THERE WAS A TINGLING IN HER FINGERTIP. THERE WAS NO INJURY REPORTED AND NO MEDICAL INTERVENTION PERFORMED.
Additional Manufacturer Narrative
THE ROOT CAUSE FOR THIS REPORTED ISSUE IS UNKNOWN. HOWEVER, NO MALFUNCTION WAS IDENTIFIED WITH THIS POWER TABLE UPON INVESTIGATION. DESCRIPTION OF CHANGES: FIELD D9: RETURNED TO MANUFACTURER CHECKBOX SELECTED. DATE RETURNED TO MANUFACTURER UPDATED TO "05/09/2023". FIELD G3: DATE RECEIVED BY MANUFACTURER UPDATED TO "05/11/2023". FIELD G6: UPDATED TYPE OF REPORT TO "FOLLOW-UP". UPDATED FOLLOW-UP NUMBER TO "1". FIELD H2: SELECTED "CORRECTION," "ADDITIONAL INFORMATION", AND "DEVICE EVALUATION". FIELD H3: UPDATED DEVICE EVALUATED BY MANUFACTURER TO "YES". EVALUATION SUMMARY ATTACHED CHECKBOX SELECTED. FIELD H6: UPDATED COMPONENT CODE TO "4755". ADDED "10" TO EXISTING LIST OF TYPE OF INVESTIGATION. UPDATED INVESTIGATION FINDINGS TO "213". UPDATED INVESTIGATION CONCLUSION TO "67". FIELD H10: ADDED NARRATIVE AND DESCRIPTION OF CHANGES.