BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE I (AU)

    MDR report key: 16620366 · Received March 27, 2023

    Report

    Report Number
    2249723-2023-01627
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 16, 2023
    Report Date
    March 22, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567109053
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4,G3,G6,H2,H10,H11. CORRECTED DATA : B5, B6,B7,D10,H6(CLINICAL & IMPACT).

    Additional Manufacturer Narrative · 0

    ADDITIONAL POINT OF CONTACT: NAME: (B)(6). OCCUPATION: TRIAL EQUIPMENT COORDINATOR IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF COIL CABLE MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED. A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND REPLACED THE COIL CABLE. REPLACED THE PNEUMATIC MODULE TO BACKPLANE CABLE. PERFORMED THE PREVENTATIVE MAINTENANCE AS PER SPECIFICATIONS.PERFORMED THE ELECTRICAL SAFETY TESTING AS PER AS3551 STANDARD.DEVICE IS WORKING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN TELEPHONE NUMBER: (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    DURING TESTING UPON RETURN FROM A CUSTOMER DEMO IF YOU 'BEND' THE CABLE THE SCREEN GOES BLANK AND THE SYSTEM ALARMS ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (SERVICE LOANER). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP GA RP CARDIOSAVE REPAIR TBA. CARDIOSAVE HYBRID (SERVICE LOANER). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP GA RP CARDIOSAVE REPAIR TBA. CARDIOSAVE HYBRID (SERVICE LOANER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690515 CARDIOSAVE HYBRID TYPE I (AU) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-31 10607567109053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown