BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAMAXX

    MDR report key: 4365330 · Received December 17, 2014

    Report

    Report Number
    3008355164-2014-00394
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    FWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED MMS SALES AND REPORTED THAT THERE WAS A PATIENT THAT HAS EXPERIENCED A "FOOT DROP" AFTER THEIR PROCEDURE AND ASKED ABOUT THE WORKINGS OF OUR SPLIT LEG PLATES AS IT APPEARS THIS WAS THE RESULT OF USER ERROR. (B)(6) HOSP HAS REQUESTED MORE TABLE IN-SERVICES FOR THEIR STAFF TO DISCUSS PROPER USE OF MAQUET AS IT WAS THOUGHT THAT THE LEG PLATE ATTACHMENT MAY NOT HAVE BEEN FULLY ATTACHED AND POTENTIALLY ROLLED OR ROTATED. MMS SALES REPORTS THAT THE TABLE IS FUNCTIONING PROPERLY AND THE LEG EXTENSION CONNECT EASILY AND PROPERLY. ADDITIONAL INFO CONCERNING THE PATIENT AND THE EVENT HAS BEEN REQUESTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829272 ALPHAMAXX NI FWZ MAQUET CARDIOPULMONARY AG 1133.22F5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention