BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE RESCUE

    MDR report key: 12385852 · Received August 30, 2021

    Report

    Report Number
    2249723-2021-01951
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    August 5, 2021
    Report Date
    March 14, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108407
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE WAS UNABLE TO EVALUATE THE IABP UNIT INVOLVED BUT WAS ABLE TO INSPECT THE REPORTED FAULTY CABLES. THE FSE OBSERVED THAT THE CABLES HAD INTERNAL BROKEN WIRES. THE CUSTOMER HAS INDICATED THAT THEY WILL BE PURCHASING THE PATIENT CABLES ON THEIR OWN. THE IABP UNIT WAS NEVER TAKE OUT OF USE, CABLES ARE AN ACCESSORY.

    Additional Manufacturer Narrative · 1

    TESTING OF ACTUAL/SUSPECTED DEVICE: A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE WAS UNABLE TO EVALUATE THE IABP UNIT INVOLVED BUT WAS ABLE TO INSPECT THE REPORTED FAULTY CABLES. THE FSE OBSERVED THAT THE CABLES HAD INTERNAL BROKEN WIRES. THE CUSTOMER HAS INDICATED THAT THEY WILL BE PURCHASING THE PATIENT CABLES ON THEIR OWN. THE IABP UNIT WAS NEVER TAKE OUT OF USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PATIENT CABLES ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279678 CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-83 N/A 10607567108407

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose