BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24727269 · Received March 30, 2026

    Report

    Report Number
    2249723-2026-0001929
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 6, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER CONTACT PHONE NUMBER: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE FAILURE MODE INVOLVED IN THE EVENT DID NOT LEAD TO AND DOES NOT HAVE POTENTIAL TO LEAD TO THE OUTCOMES OF A SERIOUS INCIDENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2026-0001929 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP) HAD A GAS LOSS ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786991 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.