BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW GAMMA CAMERA SYSTEM

    MDR report key: 2151177 · Received June 21, 2011

    Report

    Report Number
    2916556-2011-00023
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 31, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Removal / Correction Number
    C&R 2916556-6/3/11-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PINCHING HAS HAPPENED IN THE PAST WITH SKIN, CLOTHING, OR SHEETS GETTING CAUGHT BETWEEN THE STATIONARY PORTION OF THE BRIGHTVIEW TABLE AND THE EXTENDABLE PATIENT PALLET. A PALLET PAD COVER (SLICKER) WITH EXTENDED SIDES IS AVAILABLE AS AN OPTION TO IMPROVE PATIENT COMFORT. THIS COVER IS WIDE ENOUGH TO EXTEND BEYOND THE PATIENT PALLET WIDTH AND COVERS THE COMPLETE WIDTH OF THE TABLE. THE SURFACE OF THE COVER IS SUFFICIENTLY SMOOTH TO SLIDE OVER ANY NON-MOVING ELEMENTS OF THE TABLE DURING PATIENT IMAGING AND POSITIONING, THEREBY PROTECTING THE RECLINING PATIENTS' SKIN, CLOTHING, OR SHEETS FROM GETTING CAUGHT BETWEEN THE TABLE PALLET AND THE COUCH. AT THE TIME THE BRIGHTVIEW WAS RELEASED, THE SLICKER WAS NOT AVAILABLE IN THE CONFIGURATION (STANDARD OR OPTION) AT THE TIME OF PURCHASE. IT IS NOW AVAILABLE AS A FIELD REPLACEABLE UNIT AS PART NUMBER 453560817391. PHILIPS IS PROVIDING A SLICKER, FREE OF CHARGE, TO ALL THE BRIGHTVIEW CUSTOMERS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER BELIEVES THAT THE GAP BETWEEN THE STATIONARY PORTION OF THE BRIGHTVIEW TABLE AND THE EXTENDABLE PATIENT PALLET, MIGHT CAUSE HARM TO THE PATIENT, AS HAIR AND CLOTHING CAN BE PULLED INTO THE TABLE THROUGH THE GAP. THE CUSTOMER, HENCE REQUESTS SLICKER COVERS ON ALL BRIGHTVIEW SYSTEMS TO COVER UP THE GAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2170-3003A

    Patients

    Seq Age Sex Outcome Treatment
    1