BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIAMOND

    MDR report key: 2445528 · Received February 3, 2012

    Report

    Report Number
    3007120336-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    GE HUNGARY KFT
    Product Code
    IZH
    PMA / PMN Number
    K000976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS EVENT WAS ORIGINALLY REPORTED ON (B)(6) 2011, UNDER MDR 9610105-2011-00008. THE MFG SITE LOCATION IS BEING CORRECTED FROM GE HEALTHCARE (B)(4), TO GE (B)(4). THIS REPORT (MDR 3007120336-2012-00001) REPLACES MDR 9610105-2011-00008. THE DEVICE MFR DATE IS UNK. A GE HEALTHCARE FIELD ENGINEER WAS ON SITE AND EVALUATED THE DEVICE AND FOUND IT TO PERFORM ACCORDING TO SPEC. HE ALSO INTERVIEWED THE HOSP STAFF. THE RADIOGRAPHER HAD PRESSED THE PADDLE UNLOCKING BUTTON, BUT NOT ENOUGH. THE 24X30 PADDLE WAS PARTIALLY BUT NOT COMPLETELY UNLOCKED. SHE THEN TRIED TO PULL THE PADDLE ALTHOUGH IT WAS STILL LOCKED. SHE WAS IN A HURRY AS THE PT WAS PRESENT IN THE ROOM. SHE SIGNIFICANTLY FORCED TO HAVE THE PADDLE EXTRACTED AND GOT INJURED. ALSO, THE IN-SERVICE APPLICATION TRAINING DELIVERED AT THIS SITE ON (B)(6) 2011, DID COVER THE PLUG-IN/REMOVAL OF PADDLES. THE INJURED TECHNOLOGIST DID ATTEND THE IN-SERVICE TRAINING. THE DEVICE LABELING WAS REVIEWED AND PROVIDES INSTRUCTIONS FOR THE RELEASE OF THE PADDLES AS DESCRIBED IN 86528-IMG REV 3 DIAMOND QUICK USER GUIDE PARAGRAPH 2 PAGE 6 (PARAGRAPH 2) AND IN 86500-IMG DIAMOND ¿ OPERATION INSTRUCTIONS ¿ PAGE 13. THE INJURY IS ATTRIBUTED TO USER ERROR AS SHE WAS NOT FULLY FAMILIAR WITH THE OPERATION OF THE PADDLE RELEASE MECHANISM AND USED EXCESSIVE FORCE TRYING TO REMOVE A PADDLE THAT WAS STILL LOCKED. THE LEVEL OF FORCE USED WAS A DECISION OF AND UNDER FULL CONTROL OF THE OPERATOR. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECH SUSTAINED A MUSCULAR TEAR WHEN ATTEMPTING TO REMOVE A PADDLE FROM THE COMPRESSION TRAY. THE TECH REPORTEDLY RECEIVED ANTI-INFLAMMATORY MEDICATION FOR PAIN AND TOOK ONE WEEK OFF OF WORK ACCORDING TO MEDICAL RECOMMENDATION WAS REQUIRED. THERE IS NO ALLEGATION OF FAILURE OR EQUIPMENT MALFUNCTION. THE TECH WAS REPORTEDLY NOT FAMILIAR WITH HOW TO PLUG AND UNPLUG THE PADDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND MAMMOGRAPHIC X-RAY SYSTEM IZH GE HUNGARY KFT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other