BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMOPAN-1 SYSTEM

    MDR report key: 2490043 · Received March 9, 2012

    Report

    Report Number
    2910081-2012-00016
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 9, 2012
    Manufacturer
    SIEMENS MED SOLUTIONS USA, INC.
    Product Code
    JAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS (B)(4) BECAME AWARE OF THE REPORTED ISSUE ON (B)(4) 2012 AND THIS MDR IS BEING MAILED ON MARCH 8, 2012. SIEMENS DISCONTINUED SALE AND NO LONGER MANUFACTURES OR DISTRIBUTES THE DERMOPAN SYSTEMS. (B)(4).

    Description of Event or Problem · 1

    SIEMENS (B)(4) WAS NOTIFIED VIA THE (B)(4) ON (B)(4) 2012, THAT A PT RADIATION OVERDOSE OCCURRED ON (B)(6) 2012. THE INITIAL REPORT RECEIVED WAS THAT A POSSIBLE MALFUNCTION HAD OCCURRED DUE TO A COMBINATION OF INCORRECT FILTER SETTINGS, CAUSING AN OVERDOSE OF TREATMENT TO A PT. THE PT WAS NOTIFIED OF THE OVERDOSE AND WILL BE MEDICALLY OBSERVED. SIEMENS SERVICE PERSONNEL INSPECTED THE UNIT AND IDENTIFIED A BROKEN SWITCH, AND ALSO CONFIRMED THAT THE DEVICE IN QUESTION IS A DERMOPAN-1. REPORTEDLY, THE CUSTOMER HAS PERMANENTLY REMOVED THE DEVICE FROM SERVICE AND OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMOPAN-1 SYSTEM X-RAY RADIATION THERAPY SYSTEM JAD SIEMENS MED SOLUTIONS USA, INC. 01438605 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other