BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 22042558 · Received May 19, 2025

    Report

    Report Number
    2249723-2025-0002253
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERS LIMIT- EVENT SITE NAME -(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G1, G3, G6, H2, H6, H11. CORRECTED FIELDS: H6 INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RAN THE MACHINE ON BALLOON FOR 1 HOUR, NO ISSUE WAS OBSERVED FOR THE IAB CATHETER RESTRICTION ALARM. THE DEEP VACUUM TEST IN DRIVE MANIFOLD IS FAILING, CALIBRATION CHECKED FOR VACUUM AND PRESSURE SET POINT AND THE PRESSURE SET POINT IS OK, BUT THE VACUUM SET POINT IS OUT OF RANGE. THE MUFFLER IN THE VACUUM RESERVOIR IS DEFECTIVE. THE FSE REPLACED 1 FILTER VACUUM INLET AND RAN TEST. THE VACUUM INLET FILTER ( MUFFLER) HAS BEEN CHANGED, NOW THE VACUUM AND PRESSURE SET POINTS ARE CALIBRATED WITHIN RANGE. ALL PNEUMATIC AND FUNCTIONAL TESTS PASSED. MACHINE IS WORKING OK.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: H6 MEDICAL DEVICE PROBLEM CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER, CARDIOSAVE INTRA-AORTIC BALLOON PUMP WAS SHOWING IAB CATHETER RESTRICTION MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    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
    136201 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown