BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEX ELITE 9000 SS-OCT

    MDR report key: 7969536 · Received October 16, 2018

    Report

    Report Number
    2918630-2018-00002
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 26, 2018
    Report Date
    September 27, 2018
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    OBO
    PMA / PMN Number
    K161194
    Removal / Correction Number
    EVENT# 83229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AFFECTED DEVICES HAVE BEEN CORRECTED AND RECALL TERMINATED BY FDA DESCRIPTIONS OF CHANGES: FIELD G1-2: UPDATED TO "CONTACT OFFICE", FIELD G7: UPDATED TO "FOLLOW-UP #: 1", FIELD H2: UPDATED TO "CORRECTION", "DEVICE EVALUATION", FIELD H3: UPDATED "YES" AND "EVALUATION SUMMARY ATTACHED", FIELD H6: ADDED HEALTH EFFECT - IMPACT CODE TO "2199". ADDED COMPONENT CODE "473". ADDED TYPE OF INVESTIGATION '10'. UPDATED INVESTIGATION FINDINGS CODE TO "120", "144", "3257". UPDATED CONCLUSION CODE TO "12". FIELD H9: ADDED RECALL EVENT# 83229, FIELD H10: ADDED ADDITIONAL MANUFACTURER NARRATIVE AND DESCRIPTIONS OF CHANGES.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A USER HAD RECEIVED AN ELECTRIC SHOCK WHILE OPERATING THE PLEX ELITE 9000 POWER TABLE. THE USER WAS EXAMINED BY LOCAL MEDICAL PROFESSIONALS AND IT WAS REPORTED THAT THE USER HAD NOT BEEN INJURED. A PHOTO HAS BEEN PROVIDED TO THE MANUFACTURER SHOWING DAMAGED INSULATION ON A WIRE IN THE ENCLOSURE OF THE POWER TABLE'S UP/DOWN SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808758 PLEX ELITE 9000 SS-OCT TOMOGRAPHY, OPTICAL COHERENCE OBO CARL ZEISS MEDITEC, INC. 9000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1