BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTIER SURGICAL TABLE

    MDR report key: 2435310 · Received January 18, 2012

    Report

    Report Number
    2031963-2012-00006
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4) 2011. EVAL SUMMARY: THROUGH EVAL OF THE DEVICE BY A FIELD SERVICE REP, IT WAS CONCLUDED THAT THE MOTION PROCESS CONTROLLER (MPC) WAS NO LONGER FUNCTIONING WHICH LED TO THE REPORTED EVENT OF THE TABLE NOT POWERING ON. THE MPC CONTROLS THE ARTICULATIONS OF THE TABLE. IF THIS COMPONENT FAILS, THE TABLE MAY NO LONGER BE ABLE TO ARTICULATE FROM EITHER THE HAND CONTROL OR THE OVERRIDE PANEL AS WAS REPORTED IN THIS INSTANCE. IT IS UNK WHAT CAUSED THE MPC CONTROLLER TO CEASE FUNCTIONING AS THE CAUSE IS MULTI-FACTORIAL IN NATURE. FOR THIS EVENT, THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED AS THE TABLE WAS ALLEGEDLY NOT POWERING ON IN ORDER TO BE USED. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT THE VERTIER TABLE IS NOT POWERING ON AND THE HAND CONTROL AND OVERRIDE PANEL ARE NOT WORKING. THERE WAS NO REPORT OF ANY PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTIER SURGICAL TABLE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA