BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRRUS HD-OCT 6000

    MDR report key: 16678757 · Received April 4, 2023

    Report

    Report Number
    2918630-2023-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 17, 2023
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    OBO
    UDI-DI
    04057748087141
    PMA / PMN Number
    K181534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549893 CIRRUS HD-OCT 6000 CIRRUS HD-OCT OBO CARL ZEISS MEDITEC, INC. 6000 04057748087141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown