BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 23664978 · Received November 27, 2025

    Report

    Report Number
    2249723-2025-0004856
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    November 6, 2025
    Report Date
    January 29, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, B5, H2, H11, H3, E1 (EVENT SITE NAME AND ADDRESS - FULL ADDRESS AND NAME PROVIDED IN INITIAL MDR). (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). FULL NAME OF INITIAL REP: (B)(6). IT WAS DISCOVERED THAT THE MACHINE'S BACKUP BATTERY COULD NOT BE CHARGED. WHEN TURNED ON, THE DEVICE SOMETIMES DISPLAYED A DISTORTED SCREEN, MAKING IT UNUSABLE. THE FSE REPLACED THE BATTERY PACK LI-ION (D146-00-0097) ON NOVEMBER 10TH AND REPLACED THE CBL ASSY, UPPER DSP MON TO LCD (D012-00-1558) ON NOVEMBER 29TH. THE EQUIPMENT PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY TESTS. THE EQUIPMENT HAS BEEN DELIVERED TO THE CUSTOMER AND IS READY FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS BATTERY WILL NOT CHARGE AND DISPLAY FAILURE ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE EVENT OCCURRED DURING ROUTINE MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MAINTENANCE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SCREEN FLICKERED UPON POWERING ON. ADDITIONALLY, ONE OF THE SPARE BATTERIES FAILED TO CHARGE AND REMAINED STUCK WITH THE FIRST CHARGING LIGHT FLASHING FOR TWO HOURS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216312 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.