BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS HI

    MDR report key: 2841347 · Received October 23, 2012

    Report

    Report Number
    2910081-2012-08759
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2012 THAT THE PHOENIX POWER CONDITIONER UNIT BEGAN SMOKING/BURNING AND CREATED A BAD SMELL DURING PATIENT TREATMENT. REPORTEDLY, A PATIENT WAS UNDERGOING AN IMRT HEAD AND NECK TREATMENT WITH A MASK DEVICE. THE PATIENT BECAME VERY AGITATED, BEGAN WAVING THEIR ARMS AND CALLED FOR HELP DUE TO A BURNING SMELL IN THE TREATMENT ROOM. TREATMENT WAS TERMINATED BY THE THERAPISTS/OPERATORS AND THE PATIENT WAS REMOVED FROM THE TREATMENT ROOM. THERE IS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 4504200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL NO. (B)(4)| PHOENIX POWER CONDITIONER UNIT, MODEL. NO. 5504159