BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21052179 · Received January 1, 2025

    Report

    Report Number
    2249723-2025-0000031
    Event Type
    Malfunction
    Date Received
    January 1, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 6, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT RECORD IS DOWNGRADED BASED ON THE FOLLOW-UP INFORMATION. THE PARENT COMPLAINT IS DUPLICATE OF TRACKWISE RECORD (B)(4) HENCE NEED TO CANCEL THIS RECORD. NO ADDITIONAL REPORTS WILL BE SENT FOR THIS MFG REPORT NUMBER 2249723-2025-0000031.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF ADDITIONAL FINDINGS.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SOME MALFUNCTION. THERE WAS NO HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387317 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 UNKNOWN.