BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24658104 · Received March 22, 2026

    Report

    Report Number
    2249723-2026-0001798
    Event Type
    Malfunction
    Date Received
    March 22, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN MADE REPORTED INCORRECTLY UNDER MFG REPORT NUMBER 2249723-2026-0001798. PLEASE CANCEL MFG REPORT NUMBER 2249723-2026-0001798 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS- B4, G3, G6, H1, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO EVALUATE THE IABP UNIT BECAUSE THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM AND NO REPAIR INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER (REGISTERED NURSE) TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED BY THE THAT WHILE USING CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) CALLED IN TO DISCUSS AUGMENTATION AND BALLOON PUMP PRESSURES. THE BALLOON PUMP PRESSURES READ 163/126 WITH A MEAN OF 171 AND AUGMENTATION OF 213. THE PATIENT¿S NUMBERS AT THE TIME OF THE CALL WERE 88/51 WITH A MEAN OF 100 AND AUGMENTATION OF 154 WHILE HE WAS SLEEPING. THE REPORTER WANTED TO CONFIRM THAT THE BALLOON PUMP NUMBERS WERE THE MOST ACCURATE NUMBERS COMPARED TO CUFF PRESSURES, BECAUSE THE PHYSICIAN HAD TAKEN A CUFF PRESSURE WITH THE PUMP IN STANDBY. THE PRESSURE WAS IN THE 150S SYSTOLIC. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65376 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