BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D860 SEAT,CFK,STAINLESS,POWERDRV

    MDR report key: 6337498 · Received February 16, 2017

    Report

    Report Number
    0008010153-2017-00009
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 27, 2017
    Report Date
    May 16, 2017
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE D850 OR TABLE COMES UNLOCKED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED. A STRYKER FIELD SERVICE TECHNICIAN (SFST) VISITED THE ACCOUNT AND CONFIRMED THE OR TABLE WAS A D860, NOT D850 AS REPORTED BY THE CUSTOMER. THE SFST PULLED THE ERROR LOGS BEFORE AND AFTER RUNNING MULTIPLE CYCLE TESTS AND FOUND NO ISSUES WITH THE TABLE EXCEPT FOR 24V FAULTS WHICH INDICATES THAT THE TABLE BATTERIES HAD DIED. THE REPORTED ISSUE COULD NOT BE RECREATED. THE TABLE WAS VERIFIED TO BE FUNCTIONING AS INTENDED AND RELEASED BACK TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY COMES UNLOCKED. THE SITE REQUESTED TO HAVE THE CPU REPLACED. THE INVESTIGATION FOR THIS COMPLAINT IS ONGOING AND A SUPPLEMENTAL WILL BE FILED UPON COMPLETION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY COMES UNLOCKED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY COMES UNLOCKED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118249 OPERON D860 SEAT,CFK,STAINLESS,POWERDRV TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1