BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE BIPLANE

    MDR report key: 5433318 · Received February 12, 2016

    Report

    Report Number
    2240869-2016-31441
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    December 23, 2015
    Report Date
    January 22, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS CONDUCTED AN INVESTIGATION OF THE SYSTEM AND TABLE MATTRESS. NO DEFECT WAS FOUND AND THE SYSTEM AND COMPONENTS ARE OPERATING AS SPECIFIED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ADDITIONAL INFORMATION FOR INVESTIGATION WAS REQUESTED, HOWEVER, NOT SUPPLIED. THE PROBLEM WAS ALLOCATED TO A MATTRESS USED FOR PATIENT POSITIONING DURING THE PROCEDURE. THE MATTRESS IN DOUBT IS NOT A SIEMENS MEDICAL DEVICE. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS INDIVIDUAL EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A CUSTOMER EXPERIENCED A PROBLEM WITH THE MATTRESS USED DURING A PROCEDURE ON THE ARTIS ZEE BIPLANE. THE CUSTOMER STATED THE MATTRESS DID NOT PROVIDE SUFFICIENT CUSHIONING AND THE PATIENT NOTED A SACRO ILIAC PRESSURE SORE. THE HOSPITAL ADMINISTERED ROUTINE FIRST AID AND DRESSING FOR THE ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92811 ARTIS ZEE BIPLANE SYSTEM, XRAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094141

    Patients

    Seq Age Sex Outcome Treatment
    1