BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC SYSTEMS FOOT CNTRL WITH DIR/IRR

    MDR report key: 3080976 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02035
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 26, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT 1 OF 3. REPORT RECEIVED FROM (B)(6) STATING THAT DURING A SURGICAL PROCEDURE, THE DEVICE "WOULD NOT WORK EVEN THOUGH THE DOCTOR PUSHED IT WITH THEIR FOOT." IT WAS UNKNOWN IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF SPARE FOOT PEDALS WERE AVAILABLE FOR USE. PT INFORMATION WAS UNKNOWN TO THE REPORTER. IT WAS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176622 ELECTRIC SYSTEMS FOOT CNTRL WITH DIR/IRR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1