BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYDOROS ISC

    MDR report key: 223762 · Received May 13, 1999

    Report

    Report Number
    2240869-1999-00002
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    April 13, 1999
    Report Date
    April 13, 1999
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Product Code
    IZO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMAGING SYSTEM SHUT DOWN AND WOULD NOT ALLOW REBOOT WHILE ANGIO PROCEDURE BEING PERFORMED ON EMERGENCY ROOM PT. BACKUP IMAGING SYSTEM, (PORTABLE C-ARM), WAS USED TO COMPLETE PROCEDURE. PT ARRESTED SHORTLY THEREAFTER. HOSP RISK MGR STATED THAT HE BELIEVED THAT THE PT OUTCOME WAS NOT A RESULT OF THE SYSTEM SHUTDOWN WHICH OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYDOROS ISC R&F HIGH VOLTAGE GENERATOR IZO SIEMENS MEDICAL SYSTEMS, INC. 3827370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1