BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16240387 · Received January 25, 2023

    Report

    Report Number
    2249723-2023-00433
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Report Date
    January 19, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A SERVICE VISIT PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), AN ABNORMAL NOISE WAS HEARD COMING FROM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). A GETINGE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE ABNORMAL NOISE COMING FROM THE COMPRESSOR. AS SUCH, THE FSE RESOLVED THE ISSUE BY REPLACING THE SCROLL COMPRESSOR (0119-00-0236), VALVE, RELIEF (0103-17-0004), AND RESERVOIR, PRESSURE-VACUUM (0202-00-0170-03). THE FSE THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SERVICE VISIT PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), AN ABNORMAL NOISE WAS HEARD COMING FROM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025990 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 N/A.