BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTIER SURGICAL TABLE

    MDR report key: 2475954 · Received February 15, 2012

    Report

    Report Number
    2031963-2012-00013
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE NO PT DATA EXISTS. THERE IS NO EXP DATE FOR THIS PRODUCT. THE TABLE IS BEING SENT TO A THIRD PARTY FOR REPAIR. EVAL SUMMARY: THE TABLES HAVE BEEN SHIPPED TO A THIRD PARTY REPAIR COMPANY, BUT FURTHER REPAIR AND EVAL IS PENDING ARRIVAL OF REPAIR PARTS. THE ROOT CAUSE FOR THIS FAILURE IS UNK AT THIS TIME. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    STRYKER REF # (B)(4). IT WAS REPORTED THAT THE VERTIER SURGICAL TABLE IS RANDOMLY UNLOCKING. THERE WAS NO REPORTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1