BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENOPTIX QST DIGITAL IMAGING SYSTEM

    MDR report key: 2542937 · Received April 5, 2012

    Report

    Report Number
    2530069-2012-00007
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    October 26, 2011
    Report Date
    April 5, 2012
    Manufacturer
    ALARA, INC.
    Product Code
    EGY
    PMA / PMN Number
    K955643
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING INVESTIGATION RESULTS; PRODUCT UNLIKELY TO BE RETURNED. UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NURSE GOT ELECTRIC SHOCK WHILE SHE PUT THE DRUM INTO THE DENOPTIX, THERE WAS NO PT INVOLVED BUT THE NURSE GOT ELECTRIC SHOCK 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENOPTIX QST DIGITAL IMAGING SYSTEM DENTAL IMAGING PROCESSOR EGY ALARA, INC. 2011043335

    Patients

    Seq Age Sex Outcome Treatment
    1