BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS HIGH CAPACITY INTRAMEDULLARY

    MDR report key: 3030886 · Received March 28, 2013

    Report

    Report Number
    1526350-2013-00160
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUCTION ON THE ZIMMER PULSAVAC PLUS HIGH CAPACITY INTRAMEDULLARY TIP WAS NOT AVAILABLE DUE TO YELLOW PART OF THE BRUSH TIP "FITTED IN THE HOLLOW FOR SUCTION". IT WAS REPORTED THAT THE YELLOW TIP PART WAS DISCARDED BY THE HOSPITAL AND THERE WAS NO HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO ADDITIONAL INFO AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128341 PULSAVAC PLUS HIGH CAPACITY INTRAMEDULLARY PULSAVAC PLUS HIGH CAPACITY INTRAMEDULLARY FQH ZIMMER SURGICAL NA 62091697

    Patients

    Seq Age Sex Outcome Treatment
    1