BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 15556395 · Received October 6, 2022

    Report

    Report Number
    3012236936-2022-02514
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 6, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K203060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. ADDITIONAL INFORMATION: AFTER THE SURGERY, CUSTOMER TESTED PRIMING WITH OPO73, AND IT PASSED WITHOUT ANY ISSUE. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: SINCE THE MEDICAL DEVICE LOT IS UNKNOWN, THE COMPLAINT HISTORY DATA FOR INDIVIDUAL SYSTEM COULD NOT BE PERFORMED. SINCE LOT NUMBER IS UNKNOWN A MANUFACTURER RECORD REVIEW RELATED TO THE DEVICE INCLUDING DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS UNKNOWN. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRORS OCCURRED DURING ULTRASONIC WAS OSCILLATED WHEN MODE WAS CHANGED FROM DIA TO PHACO 1. THE ERRORS WERE 160 (GAS FORCE INFUSION PRESSURE IS TOO LOW) AND 161 (GAS FORCE INFUSION PRESSURE IS TOO HIGH). VRT-AI (VERITAS ADVANCED INFUSION PACK) WAS REPORTEDLY NOT REUSED FOR MULTIPLE PATIENTS. CUSTOMER REPLACED TUBING PACK; HOWEVER, THE ISSUE WAS NOT RESOLVED. CUSTOMER DID NOT REBOOT THE MACHINE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP MACHINE. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN THE PROBLEM WAS CAUSED BY VRT-AI OR VERITAS CONSOLE. THIS EVENT WILL CAPTURE INFORMATION FOR VRT_AI, A SEPARATE MDR IS BEING SUBMITTED FOR VERITAS CONSOLE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387806 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT-AI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MODEL VRT680300 SN (B)(4)