BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE I (AU)

    MDR report key: 18722837 · Received February 16, 2024

    Report

    Report Number
    2249723-2024-00705
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 6, 2024
    Report Date
    December 26, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109053
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) HASN'T ATTENDED AS THE CUSTOMER HAS NEVER PROVIDED A PURCHASE ORDER (PO). FSE HAVE BEEN ADVISED BY MANAGEMENT TO CLOSE ALL CASES OLDER THAN 60 DAYS WITH NO ACTION. THE INVESTIGATION SHALL BE CLOSED NOW. IF ANY OTHER ADDITIONAL INFORMATION RECEIVED ABOUT SERVICE THE COMPLAINT WILL BE REOPENED AND UPDATED IT. CUSTOMER HAS NEVER PROVIDED A PURCHASE ORDER.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, G3, G6, H2, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS),H10. IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CARDIOSAVE LIQUID DAMAGE ON PCB. GETINGE FIELD SERVICE ENGINEER (FSE) INTERNAL NOTE. WE ARE WAITING FOR THE CUSTOMER TO APPROVE THE QUOTE TO GO ONSITE. ONCE THE QUOTE IS APPROVED AND THE FSE GOES ONSITE, MORE INFORMATION CAN BE REQUESTED BY THE RELEVANT FSE. NO PATIENT INVOLVED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNRELATED SERVICE VISIT BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD LIQUID DAMAGE FOUND ON FRONT END PCB. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450820 CARDIOSAVE HYBRID TYPE I (AU) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-31 10607567109053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown