BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE RESCUE

    MDR report key: 15624954 · Received October 18, 2022

    Report

    Report Number
    2249723-2022-02688
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    October 10, 2022
    Report Date
    March 4, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108407
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION : (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT, CART HANDLE WILL NOT RETRACT. REPLACED DAMAGED PARTS.( 040-00-0458-03) SCREW KIT, CARDIOSAVE CONSOLE WHEEL,(D380-00-0561) DISPLAY, UPPER HINGE COVER ,(D997-00-0588) ASSEMBLY WHEELS ,(D997-00-0587) SLIDE HANDLE ,(D441-00-0194) COVER, CONSOLE UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE EQUIPMENT WAS CLEARED FOR CUSTOMER USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS TRANSPORT HANDLE DOES NOT GO UP AND THE WHEELS WILL NOT OPEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS TRANSPORT HANDLE DOES NOT GO UP AND THE WHEELS WILL NOT OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306137 CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-83 10607567108407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown