BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 16225150 · Received January 23, 2023

    Report

    Report Number
    2249723-2023-00304
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    August 7, 2020
    Report Date
    January 11, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT DISCOVERED THE ISSUE LATER CONFIRMED THAT THE CORRECT PARTS WERE RECEIVED. 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 BY A GETINGE FIELD SERVICE ENGINEER THAT FOUR SPRINGS RATHER THAN FOUR SCREWS (D212-12-0832) WERE RECEIVED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615968 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown