BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16845854 · Received May 1, 2023

    Report

    Report Number
    2249723-2023-02151
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 19, 2023
    Report Date
    March 6, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1 (SITE COUNTRY), G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10 ADDITIONAL POINT OF CONTACT: CONTACT PERSON NAME: ROBERT H, CONTACT DEPARTMENT: BIOMED A GETINGE FIELD SERVICE ENGINEER (FSE) STATED DURING PREVENTIVE MAINTENANCE (PM) HE FOUND THE IABP MISSING THE TOP BIN ASSEMBLY. TO RESOLVE THE ISSUE HE INSTALLED MENTIONED PARTS: D380-00-0539 STORAGE BIN, TOP, D441-00-0196 CHASSIS, STORAGE BINS, D406-00-0947 BRACKET, MOUNT, DOPPLER STRG, D997-00-0596 ASSEMBLY, TETHER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS MISSING TOP DRAWER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566484 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 NA Unknown N.A