BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFX

    MDR report key: 6058793 · Received October 26, 2016

    Report

    Report Number
    2921578-2016-00019
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    June 19, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE SPAR WAS BENT AROUND SOME OBSTACLE UNTIL IT BROKE. THIS MAY HAVE HAPPENED WITH THE PATIENT ON THE TABLE, OR A PREVIOUSLY BENT AND CRACKED SPAR MAY HAVE BEEN USED TO SUPPORT THIS PATIENT, WITH FURTHER CRACKING OCCURRING WHEN PATIENT WAS REPOSITIONED. THE FACILITY EXPLAINED THAT THE REPORTED "ONGOING PROBLEMS WITH DIFFERENT OR TABLES" REFERS TO TWO OTHER DEVICES THAT WERE DAMAGED AND REQUIRED REPAIRS, WITH NO PATIENT INVOLVEMENT. THIS IS NOT NORMAL USE AND THE FACILITY HAS DECLINED TO EXPLAIN WHAT THEY WERE TRYING TO DO. NO EVIDENCE OF DESIGN PROBLEM.

    Description of Event or Problem · 1

    PATIENT WAS REPOSITIONED AND THE LEFT SPAR WAS HEARD BY STAFF AS A LOUD CRACKING NOISE. UPON EXAMINATION OF THE TABLE, A LARGE CRACK WAS IDENTIFIED. THE CARBON FIBER MATERIAL WAS CRACKED. HOSPITAL HAS HAD ONGOING PROBLEMS WITH DIFFERENT O.R TABLES SUPPLIED BY (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REPOSITIONED AND THE LEFT SPAR WAS HEARD BY STAFF AS A LOUD CRACKING NOISE. UPON EXAMINATION OF THE TABLE, A LARGE CRACK WAS IDENTIFIED. THE CARBON FIBER MATERIAL WAS CRACKED. HOSPITAL HAS HAD ONGOING PROBLEMS WITH DIFFERENT OR TABLES SUPPLIED BY MIZUHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708750 PROFX PROFX TABLE, 120V (450 LBS.) JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other