BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16073557 · Received December 29, 2022

    Report

    Report Number
    2249723-2022-03496
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    May 15, 2020
    Report Date
    November 18, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TERRITORY MANAGER (STM) HAS ADVISED THAT THE CUSTOMER IS WAITING ON PURCHASE ORDER (PO) APPROVAL FROM THE FACILITIES CHIEF FINANCIAL OFFICER (CFO). AT THIS TIME, GETINGE HAS NOT RECEIVED A RESPONSE FROM THE CUSTOMER REGARDING THE STATUS OF APPROVAL. NO REPAIR HAS BEEN PERFORMED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THIS ADDITIONAL INFORMATION IS RECEIVED. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4). EVALUATION NOT REQUESTED BY COMPLAINANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A BLOOD BACK EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2766579 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown