BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4

    MDR report key: 1083252 · Received July 25, 2008

    Report

    Report Number
    MW5007811
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    SIEMENS
    Product Code
    IYX
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIEMENS DELAYING OR REFUSING TO SUPPLY AIAT INFO PER 21CFR 1020.30 AND 1020.33 FOR THE SIEMENS VOLUME -ACCESS- ZOOM, SENSATION PLUS 4, SOMATOM EMOTION, SOMATOM ESPRIT, SOMATOM BALANCE, SPC

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4 SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4 IYX SIEMENS SIEMENS VOLUME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SPC| SOMATOM EMOTION| SENSATION PLUS 4| SOMATOM BALANCE| SOMATOM ESPIRIT| SIEMENS VOLUME ACCESS ZOOM