BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 25090545 · Received May 6, 2026

    Report

    Report Number
    2249723-2026-0002525
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 6, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11 CORRECTED FIELDS: E1(EVENT SITE EMAIL) THE FSE SWAPPED THE BATTERY FROM POWER SLOT 2 TO POWER SLOT 1 AND THE LITHIUM BATTERY STILL WOULD NOT CHARGE. IT WAS CONFIRMED IN THE POWER PARAMETER MENU THAT THE REMAINING CAPACITY (MWH) WAS DROPPING FOR THAT BATTERY. AS ONLY 1 BATTERY FAILED THE FSE REPLACED BOTH LITHIUM BATTERIES OUT OF PRECAUTION. CONFIRMED BOTH NEW BATTERIES X2 WERE CHARGING AND THE LED¿S WERE ILLUMINATED AND BLINKING WHILE PLUGGED IN AC POWER. THE UNIT PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP)¿S BATTERY WON'T HOLD A CHARGE EVEN WHILE PLUGGED IN. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99355 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