BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS ISPAN

    MDR report key: 7768899 · Received August 9, 2018

    Report

    Report Number
    7768899
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REGULATOR ON THE SF6 TANK HAS NOT BEEN FUNCTIONING CORRECTLY TO OBTAIN THE GAS. THE REGULATOR CANNOT BE RELIED UPON TO WORK AND HAS NOT WORKED CORRECTLY ON MULTIPLE OCCASIONS. MESSAGES TO THE COMPANY HAVE BEEN SENT. MANUFACTURER RESPONSE FOR REGULATOR, VITREORETINAL REGULATOR (PER SITE REPORTER). UNSATISFACTORY RESPONSE TO DATE - NO RESPONSE, NO RESOLUTION. THERE IS A LONG-STANDING HISTORY OF NO RESPONSE FROM THIS COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610930 ACCURUS ISPAN UNIT, PHACOFRAGMENTATION HQC ALCON LABORATORIES, INC. 8065797303 711606

    Patients

    Seq Age Sex Outcome Treatment
    1 32120 DA