BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21443772 · Received February 24, 2025

    Report

    Report Number
    2249723-2025-0000830
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 29, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- INITIAL REPORTER-(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT RECORD IS DOWNGRADED BASED ON THE FOLLOW-UP INFORMATION. THIS IS NOT A VALID COMPLAINT SINCE BOTH SAFETY DISK AND TIDAL VOLUME DISK WERE DUE FOR REPLACEMENT DUE TO EXPIRATION OR CYCLES. NO ADDITIONAL REPORTS WILL BE SENT FOR THIS MFG REPORT NUMBER 2249723-2025-0000830.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) REQUIRED SAFETY DISK AND TIDAL VOLUME DISK REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528495 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown