BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 13052746 · Received December 21, 2021

    Report

    Report Number
    2249723-2021-02915
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 26, 2021
    Report Date
    March 15, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE (10/3233): TESTING OF ACTUAL/SUSPECTED DEVICE (10/3233): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. THE FSE FOUND THAT THE SOLENOID BOARD HAD A SMOKED COMPONENT WHICH A DAMAGED MOTOR CONTROL BOARD. THE FSE ORDERED THE NEEDED PARTS AND RETURNED TO COMPLETE THE REPAIR ON A SUBSEQUENT DAY. THE FSE REPLACED THE SOLENOID AND MOTOR CONTROL BOARD WITH NO SUCCESS. THE FSE ORDERED THE POWER MANAGEMENT AND BACKPLANE BOARD. ON A DIFFERENT DATE THE FSE REPLACED THE POWER MANAGEMENT BOARD. A FULL CALIBRATION AND FUNCTIONAL CHECK WAS PERFORMED PER THE FACTORY CALIBRATION PROCEDURES. THE UNIT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4,D9,E1(SITE COUNTRY),G3,G6,H2,H4,H6(TYPE OF INVESTIGATION,INVESTIGATION FINDINGS,COMPONENT CODE, INVESTIGATION CONCLUSIONS),H10,H11. CORRECTED FIELD - H3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUTDOWN UNEXPECTEDLY AND THE SCREEN WENT BLANK. IN ADDITION, THE USER STATED THAT A HIGH PITCH SQUEAL WAS HEARD AND A BURNING ODOR WAS COMING FROM THE UNIT. A SECOND CARDIOSAVE WAS RETRIEVED AND THE PATIENT THERAPY WAS TRANSFERRED TO THAT CONSOLE. THE THERAPY WAS RESUMED WITH MINIMAL DOWNTIME. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950606 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-45 N/A 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown