BEUDAMED
    FDA Adverse Event Summary report: N

    BIGBORE (BB() ONCOLOGY

    MDR report key: 3003991 · Received February 26, 2013

    Report

    Report Number
    1525965-2013-00031
    Date Received
    February 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THE OPERATOR WAS PRESSING THE UNLOAD PEDAL ON THE MULTI-FUNCTION FOOTSWITCH TO REMOVE A PATIENT AND THE COVER WAS LOOSE ON THE UNLOAD FOOTSWITCH. THERE WAS NO HARM TO A PATIENT OR OPERATOR AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81661 BIGBORE (BB() ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1