BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20859495 · Received December 5, 2024

    Report

    Report Number
    2249723-2024-0004952
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 13, 2024
    Report Date
    May 27, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1: (B)(6) HOSPITAL, CARDIOVASCULAR AND RESPIRATORY DISEASE CENTER A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT BUT WAS UNABLE TO CONFIRM THE REPORTED MALFUNCTION. THE FSE CONFIRMED THE ERROR IN THE LOGS. THE FSE REPLACED THE EXECUTIVE PROCESSOR BOARD (0670-00-0770), FRONT END BOARD (0670-00-1164), AND THE BACKPLANE BOARD (0670-00-1163) AS A PREVENTATIVE MEASURE. THE UNIT WAS RAN FOR ABOUT A WEEK AND NO RECURRENCE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN INTERNAL COMMUNICATION ERROR (#115), DUE TO THE SHUTDOWN THE SCREEN WAS NOT DISPLAYED AND THE DEVICE WAS REPLACED IN A FEW MINUTES AND TREATMENT CONTINUED. THERE WERE NO REPORTS OF HEALTH DAMAGE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376531 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