BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTIER SURGICAL TABLE

    MDR report key: 2833294 · Received October 26, 2012

    Report

    Report Number
    2031963-2012-00149
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS REPORTED PT INVOLVEMENT, HOWEVER, THE HOSP DECLINED TO PROVIDE ANY PT INFO. EVAL SUMMARY - IT WAS REPORTED THAT A SECTION OF THE VERTIER SURGICAL TABLE WAS REPORTEDLY UNLOCKING ON IT'S OWN. THE TABLE HAS BEEN RETURNED BUT HAS NOT BEEN EVALUATED YET. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT SECTIONS OF A VERTIER SURGICAL TABLE ALLEGEDLY DID NOT LOCK INTO PLACE PROPERLY WHILE IN USE DURING A CASE. THE HOSPITAL STAFF WAS ABLE TO PREVENT THE PT FROM FALLING OFF THE TABLE, AND THERE WAS NO REPORT OF A SIGNIFICANT PROCEDURAL DELAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1