BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16264979 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00724
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    March 2, 2021
    Report Date
    January 13, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE TOP ENCLOSURE PANEL (0997-00-0644) WITH LABELS (0334-00-1811 & 0334-00-1813). THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. 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 WHILE SERVICING A UNIT AS TO AN UNRELATED REPORTED ISSUE, THE GETINGE FIELD SERVICE ENGINEER (FSE), DISCOVERED THAT THE FIBER-OPTIC DOOR ON THE TOP ENCLOSURE PANEL OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15104 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown