BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLOT

    MDR report key: 16500528 · Received March 8, 2023

    Report

    Report Number
    3013155768-2023-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Report Date
    March 6, 2023
    Manufacturer
    ENDOCLOT PLUS CO., LTD.
    Product Code
    BTI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    RECEIVED THE NOTICE FROM THE DISTRIBUTOR CLAIMING THE CUSTOMER SERVICE AGENT AND SALES RECEIVED A TEXT FROM THE CUSTOMER CLAIMING AN ENDOCLOT AIR COMPRESSOR DOES NOT HAVE ENOUGH AIR FLOW. THERE WAS NO DEATH, INJURY OR INFECTION RELATED TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121387 ENDOCLOT ENDOCLOT AIR COMPRESSOR BTI ENDOCLOT PLUS CO., LTD. EPAC-2 D122055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown