BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7946354

    MDR report key: 7946354 · Received October 9, 2018

    Report

    Report Number
    7946354
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    April 30, 2018
    Report Date
    September 26, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MAMMO TECH WAS PERFORMING A MAMMOGRAM ON A PATIENT AND THE MACHINE STARTING MAKING A GRINDING NOISE AND DID NOT TAKE THE EXPOSURE CORRECTLY. THE PATIENT WAS NOT EFFECTED AND DOES NOT NEED TO COME BACK, THE RADIOLOGIST FOUND THE IMAGES ADEQUATE. AFTER THE PATIENT LEFT, THE MAMMO TECH TRIED TAKING IMAGES USING A PHANTOM BUT THE PROBLEM PERSISTED. THE MAMMO TECH THEN CALLED HOLOGIC AND GAVE THEM THE ERROR CODES THAT CAME UP ON THE MAMMO UNIT. HOLOGIC SAID THAT IS A PROBLEM WITH THE GRID IN THE BUCKY, A REPLACEMENT PART HAS BEEN ORDERED AND IS BEING SHIPPED OVER NIGHT. THERE WILL BE SOMEONE HERE IN THE MORNING TO RESOLVE THIS ISSUE. PATIENTS FOR THE REMAINDER OF TODAY AND TOMORROW MORNING ARE BEING CALLED AND RESCHEDULED. MANUFACTURER RESPONSE FOR MAMMOGRAPHY MACHINE, SELENIA DIMENSIONS (PER SITE REPORTER). ALPHA IMAGING DISPATCHED TO SITE. GRID REPLACEMENT WAS REQUIRED AND GRID RECALIBRATION WAS DONE. THE TECH PERFORMED PHANTOM QC FOLLOWING REPLACEMENT AND THE RESULTS WERE WITHIN REGULATIONS.

    Patients

    Seq Age Sex Outcome Treatment
    0 24820 DA