BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16691791 · Received April 6, 2023

    Report

    Report Number
    2249723-2023-01803
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 28, 2023
    Report Date
    November 3, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT. WHEN THE JACK PLUG THAT COMES FROM THE CS IS CONNECTED TO THE MONITOR, THERE IS NO SIGNAL. NOW IF YOU DO THAT YOU ONLY GET A SIGNAL BY PLUGGING THE JACK PLUG CABLE INTO THE 2ND CONTACT IN THE MONITOR. AS SOON AS YOU CONNECT THE MASS OF THE MONITOR WITH THE MASS, THE CS CONNECTS AND YOU NO LONGER HAVE A SIGNAL. THIS FACT WAS PASSED ON FOR ANALYSIS. AFTER CONSULTING WITH THE BA CA, WE WERE GIVEN THE INFORMATION. THIS DESCRIBES JUMPERS 7 AND 6 FROM RIGHT TO LEFT BE REPLUGGED. THIS CHANGES THE SIGNAL FROM NON-GROUND REFERENCED TO GROUND REFERENCED. JUMPERS 6 AND 7 WERE REPOSITIONED ACCORDING TO INSTRUCTIONS. FUNCTION CHECKED AND DEMONSTRATED TO CUSTOMERS. THE DEVICE IS HANDED BACK TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN SETTING UP , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT DOES NOT RECOGNIZE THE ECG FROM THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853771 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown