BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 18608742 · Received January 30, 2024

    Report

    Report Number
    2249723-2024-00366
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 19, 2024
    Report Date
    December 23, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED WITH A NEW SOLENOID DRIVER PCB AND THE PROBLEM WAS STILL PERSISTING. THE FSE THEN CHECKED ALL PNEUMATICS AND STATED THAT EXPERT LEVEL SUPPORT WAS REQUIRED. THE FSE THEN CHECKED THE UNIT WITH A NEW FRONT END PCB , EXECUTIVE PROCESSOR BOARD , VIDEO GENERATOR BOARD , PIM MODULE UNIT WITH COIL CABLE, BUT PROBLEM WAS STILL PERSISTING AND STATED THAT THE UNIT NEEDED TO BE CHECKED WITH THE PNEUMATIC ASSEMBLY. THE FSE REPLACED THE PNEUMATIC ASSEMBLY AND THE BOOTING PROBLEM WAS RESOLVED. THE FSE THEN OBSERVED THE UNIT GIVING ERROR POWER UP TEST FAILURE CODE #10. THE FSE SUSPECTED THE BACK PLANE BOARD THAT NEEDED TO BE CHECKED WITH A WORKING BOARD. THE FSE REPLACED THE BACK PLANE BOARD WHICH RECTIFIED ISSUE. THE FSE THEN REITERATED THAT THE BACK PLANE BOARD (0670-00-1163), FRONT END PCB (0670-00-1164) ,PNEUMATIC INTERFACE PCB ,AND DRIVE MANIFOLD, WERE REPLACED AND THE FAULT WAS RECTIFIED. THE FSE TESTED AND HANDED OVER THE UNIT IN GOOD WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SERVICE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS NOT BOOTING AND GIVING LONG ALARM . THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251192 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-33

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.