BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 14461554 · Received May 20, 2022

    Report

    Report Number
    2249723-2022-01194
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 27, 2022
    Report Date
    March 29, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE : A GETINGE FIELD SERVICE ENGINEER (FSE) HAS INVESTIGATED, BUT THE REPAIR IS PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. THE FULL EVENT SITE NAME IS (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, E1(SITE COUNTRY, EVENT SITE POSTAL CODE - 196-0003, EVENT SITE STATE - TOKYO), G3, G6, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER WITH REGARD TO THE REPAIR AND STATUS OF THE IABP; HOWEVER, DESPITE OUR BEST EFFORTS, NO REPAIR INFORMATION AND NO STATUS OF THE IABP HAS BEEN RECEIVED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PRE-DELIVERY INSPECTION IT WAS OBSERVED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD RIVETS IN THE CART THAT WERE FALLING OFF. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367981 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown