BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAXITRON

    MDR report key: 17610296 · Received August 24, 2023

    Report

    Report Number
    17610296
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 27, 2023
    Report Date
    July 31, 2023
    Manufacturer
    HOLOGIC
    Product Code
    MWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIOVISION WOULD NOT TURN ON. MANUFACTURER RESPONSE FOR RADIOGRAPHIC UNITS SPECIMEN DIGITAL, BIOVISION (PER SITE REPORTER). THERE IS A SERVICE CONTRACT IN PLACE AND SERVICE HAS BEEN NOTIFIED TO FIX THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251550 FAXITRON CABINET,X-RAY SYSTEM MWP HOLOGIC BIOVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown