BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 17763924 · Received September 18, 2023

    Report

    Report Number
    2249723-2023-04081
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Report Date
    April 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9,E1(INITIAL REPORTER),E2,E3,G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: D5. ADDITIONAL FIELDS: E1 (B)(6). IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CONTINUES BEEPING WHEN SWITCHING ON. A GETINGE FIELD SERVICE ENGINEER EVALUATED OBSERVED THAT SYSTEM IS SHOWING CONTINUOUS BEEP SOUND WHEN SWITCHING ON THE SYSTEM. PROBLEM SUSPECTED WITH POWER MANAGEMENT BOARD. REPLACED NEW POWER MANAGEMENT BOARD (D670-00-1162)AND UPDATED LATEST SOFTWARE. THEN CHECKED THE SYSTEM IT IS BOOTING UP BUT AFTER SOME TIME AUTOMATICALLY TRYING BOOT AGAIN AND AGAIN THEN FINALLY CONTINUES BEEPING. VIDEO GENERATOR BOARD KIT(D040-00-0456) REPLACED WHICH TOUCH SCREEN NOT WORKING PROPERLY. ALARM DATA BOARD(D670-00-0860) REPLACED THEN SYSTEM SHOWING ELECTRICAL TEST FAILURE #10 SO REPLACED FRONT END BOARD AND EXECUTIVE PROCESSOR BOARD (D670-00-0770) THEN PERFORMED ALL CALIBRATION. SWITCHING ON/OFF SEVERAL TIMES THEN CHECKED WITH DEMO BALLOON AND TRAINER IT IS WORKING FINE AND READY TO USE. IT IS UNKNOWN OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN SWITCHING ON, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT CONTINUES BEEPING.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302784 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown