BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24276595 · Received February 6, 2026

    Report

    Report Number
    2249723-2026-0001115
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 5, 2026
    Report Date
    April 24, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THEY WERE ABLE TO REPRODUCE THE NON CHARGING ISSUES. THE POWER SLOT INTERFACE BOARD (0997-00-1187) AND POWER MANAGEMENT BOARD (0670-00-1162) WERE REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PARTS WITH A REPORTED UNIT FAILURE OF THE BATTERIES NOT CHARGING AND A BENT PIN ON POWER SLOT INTERFACE BOARD. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND TO HAVE A BENT PIN. SEE ATTACHMENT. THIS WOULD CAUSE THE BATTERY TO NOT FIT PROPERLY AND CHARGE. POSSIBLE CAUSE MAY BE A USER OPERATIONAL CONTEXT ISSUE. THE FAT INSTALLED 0670-00-1162 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE FST DURING ROUTINE INSPECTION THAT THE BATTERY OF CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD CHARGING ISSUE. 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
    344592 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