BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGBORE (BB) ONCOLOGY

    MDR report key: 2992392 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00033
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    July 13, 2012
    Report Date
    July 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. AN INVESTIGATION DETERMINED THAT THE PROBABLE ROOT CAUSE IS A POOR FIT OF THE FRONT CONE (GAP BETWEEN THE BOTTOM OF THE FRONT CONE ASSEMBLY AND THE BOTTOM GANTRY COVER) AND SUGGESTED THAT THE FRONT CONE ASSEMBLY BE REPLACED.(B)(4).

    Description of Event or Problem · 1

    PHILIPS REC'D A REPORT THAT THE FIELD SAFETY ENGINEER (FSE) WAS CLEANING THE GANTRY DURING MAINTENANCE AND STUCK THEIR FINGER IN A GAP UNDERNEATH THE GANTRY'S FRONT COVER AND REC'D A DEEP CUT (2-3MM). IT WAS REPORTED THAT THE FSE DID NOT REQUIRE STITCHES AND EXPERIENCED NO LONG TERM EFFECT DUE TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89475 BIGBORE (BB) ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1