BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER TABLE

    MDR report key: 4329071 · Received November 19, 2014

    Report

    Report Number
    2918630-2014-00001
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 13, 2014
    Report Date
    March 21, 2016
    Manufacturer
    CARL ZEISS MEDITEC INC
    Product Code
    HRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ADDED MANUFACTURER NARRATIVE: A QUALITY ENGINEER (QE) PERFORMED AN IN-HOUSE INSPECTION OF THE POWER TABLE. THE QE FOUND THAT THE TABLE WAS MISSING A SOLDERING WELD SPECIFIED BY THE DESIGN. THE MANUFACTURER REPLACED THE TABLE AT THE CUSTOMER SITE. CORRECTION: ON INITIAL REPORT SHOULD HAVE BEEN "11/19/2014" INSTEAD OF "10/19/2014". UPDATE: METHOD AND CONCLUSIONS.

    Description of Event or Problem · 1

    NA

    Description of Event or Problem · 1

    A PERIMETER AND POWER TABLE HFA 120 WERE SET UP AT A CUSTOMER SITE BY A CONTRACTOR IN PREPARATION FOR ON-SITE STAFF TRAINING BY THE MANUFACTURER'S CLINICAL APPLICATIONS SPECIALIST. A FIELD SERVICE ENGINEER, ON-SITE FOR A DIFFERENT REASON, NOTICED THAT THE POWER TABLE WAS WOBBLY. HE INSPECTED THE TABLE AND DETERMINED THAT THERE WAS A PROBLEM WITH THE WELD JOINING THE COLUMN TO THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748791 POWER TABLE TABLE INSTRUMENT POWERED OPHTHALMIC HRJ CARL ZEISS MEDITEC INC HFA 120

    Patients

    Seq Age Sex Outcome Treatment
    1