BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN INTRA-AORTIC BALLOON

    MDR report key: 12673634 · Received October 21, 2021

    Report

    Report Number
    2248146-2021-00688
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 13, 2021
    Report Date
    December 16, 2021
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. REFERENCE COMPLAINT #(B)(4)

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED AND BLOOD WAS SEEN BACKING UP INTO THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573027 UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARDIOSAVE| CARDIOSAVE