BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22791498 · Received August 13, 2025

    Report

    Report Number
    2249723-2025-0003475
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    November 19, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, G3, G6, H2, H11. CORRECTED FIELDS: H6 (COMPONENT CODES, INVESTIGATION CONCLUSIONS). THE SAFETY DISK (0202-00-0140), TIDAL VOLUME DISK (0202-00-0142), AND BATTERIES (0146-00-0146) WERE REPLACED AS PART OF ITS PERIODIC MAINTENANCE, NOT DUE TO THE PUMP FAILURE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD A POWER UP TEST FAILS CODE #14. IT IS UNKNOWN IF A PATIENT WAS INVOLVED, BUT PATIENT HARM WAS REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT CONFIRMED PROBLEM STATED BY CUSTOMER. PER SERVICE MANUAL SCROLL COMPRESSOR NEEDS TO BE REPLACED. THE FSE REMOVED AND REPLACED THE SCROLL COMPRESSOR (0119-00-0236). ALSO, THE SAFETY DISK (0202-00-0140), TIDAL VOLUME DISK (0202-00-0142), AND BATTERIES (0146-00-0146) WERE REPLACED AS PART OF ITS PERIODIC MAINTENANCE, NOT DUE TO THE PUMP FAILURE. THE FSE PERFORMED A FULL PM PER MANUFACTURE SPECIFICATIONS AND THE UNIT HAS PASSED ALL TEST AND CALIBRATIONS. THE UNIT IS NOW READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD POWER UP TEST FAILS CODE #14. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763724 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