BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21891065 · Received April 23, 2025

    Report

    Report Number
    2249723-2025-0001922
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    April 4, 2025
    Report Date
    August 21, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION IN BLOCK E1: EVENT SITE NAME: (B)(6). EVENT SITE ADDRESS: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELD- B4, G3, G6, H2, H11. CORRECTED FIELD- H6- COMPONENT CODES.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS :B4, B5, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3 H6(HEALTH EFFECT ¿ CLINICAL CODE, MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS,) H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. SUCCESSFULLY COMPLETED A SIMULATED TREATMENT ON UNIT WITH TESTING CATHETER AND TRAINER WITHOUT ISSUE UPON INITIAL TESTING. IDENTIFIED BROKEN DOPPLER TRAY HINGES BROKEN. POST REPLACING CHASSIS BIN STORAGE (D441-00-0196), SUCCESSFULLY COMPLETED A FULL SYSTEM CHECKOUT WITHOUT ISSUES. NOTHING WRONG WITH THE COMPRESSOR. UNIT CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. SERVICE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) COMPRESSOR OVERHEATS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DAILY CHECKS THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD COMPRESSOR OVERHEAT. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726683 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 N/A.