BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGO IMAGING SYSTEM

    MDR report key: 14438297 · Received May 19, 2022

    Report

    Report Number
    2031050-2021-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 21, 2021
    Report Date
    March 5, 2021
    Manufacturer
    DIGIRAD CORPORATION
    Product Code
    IYX
    UDI-DI
    00850816007003
    PMA / PMN Number
    K123408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REPAIRED BY DIGIRAD TECHNICIAN BEFORE CONTINUED USE. SERVICE BULLETIN 127285 INSTRUCTIONS, RETROFIT KIT 54, ERGO COLLIMATOR LATCH PLUNGER INSPECTION AND/OR REPLACEMENT WAS RELEASED 2021-05-19 TO PROVIDE ADDITIONAL INSTRUCTIONS TO END USERS REGARDING MAINTENANCE OF THE DEVICE. INVESTIGATION WAS COMPLETED AND DOCUMENTED UNDER CAPA SYSTEM, (B)(4).

    Description of Event or Problem · 0

    CUSTOMER STATED THAT THE COLLIMATOR FELL OFF OF A HEAD AND HIT A NUC TECH FOOT AFTER A "STUDENT" INSTALLED IT. BROKEN FOOT INJURY TO THE TECHNICIAN. PATIENT FOLLOWED UP WITH OCCUPATIONAL HEALTH SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224613 ERGO IMAGING SYSTEM CAMERA, SCINTILLATION (GAMMA) IYX DIGIRAD CORPORATION 00850816007003

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention