BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16831506 · Received April 28, 2023

    Report

    Report Number
    2249723-2023-02118
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 17, 2023
    Report Date
    March 7, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELDS: H6 (INVESTIGATION FINDINGS). ADDITIONAL CUSTOMER CONTACT INFORMATION: NAME: (B)(6), E-MAIL: (B)(6) OCCUPATION: BIOMEDICAL ENGINEER, PHONE: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING D441-00-0196 CHASSIS,STORAGE BINS. CALIBRATED AND PERFORMED FUNCTIONAL TESTING TO THE UNIT. THE EQUIPMENT WAS CLEARED FOR CUSTOMER USE.

    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

    WHILE EVALUATING THE UNIT GETINGE FIELD SERVICE ENGINEER REPORTED THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS BROKEN CHASSIS STORAGE BINS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336874 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