BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 16236966 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00416
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    January 20, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE SERVICE TERRITORY MANAGER (STM) WHO ENCOUNTERED THE ISSUE INDICATED THAT THERE WERE NO ADDITIONAL PARTS IN STOCK IN THE FIELD OR WAREHOUSE. ONCE THE NEW PARTS WERE RECEIVED THE STM WAS ABLE TO REPAIR THE UNIT AND CLEAR IT FOR CLINICAL USE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GETINGE SERVICE TERRITORY MANAGER (STM) ORDERED 0212-12-0832 " SCREWS" BUT RECEIVED SPRINGS INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034420 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0212-12-0832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown