BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20683377 · Received November 14, 2024

    Report

    Report Number
    2249723-2024-0004685
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 21, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9(DEVICE AVAILABLE FOR EVAL), G3, G6, H2, H3, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE AC POWER CORD REEL (0012-00-1688-01). THE FSE ALSO DISCOVERED SEVERAL DAMAGED PARTS. THE FSE REPLACED THE CHASSIS STORAGE BINS (0441-00-0196), AND THE DOPPLER RETRACTOR (0997-00-0596), AND THE 1/8 NPT MUFFLER (0103-00-0631). THE FSE PERFORMED A COMPLETE PREVENTIVE MAINTENANCE (PM) WITH FULL CALIBRATION. THE UNIT PASSED ALL FUNCTIONAL AND ELECTRICAL SAFETY TESTS PER FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GROUND PRONG MISSING ON THE AC LINE CORD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350111 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown