BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23954828 · Received January 5, 2026

    Report

    Report Number
    2249723-2026-0000152
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 16, 2025
    Report Date
    March 22, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- (B)(6).

    Additional Manufacturer Narrative · 0

    CONTACT PERSON PHONE NUMBER: (B)(6). UPDATED FIELDS B4 D9 E3 G3 G6 H2 H3 H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS COMPONENT CODE CONCLUSION H11. CORRECTED FIELD E1 INITIAL REPORTER NAME. IT WAS REPORTED THAT PRIOR TO USE THE CARDIOSAVE INTRA AORTIC BALLOON PUMP IABP DISPLAYED ERROR CODE 53 FIBER OPTIC FAIL. NO PATIENT WAS INVOLVED AND NO HARM WAS REPORTED. A GETINGE FIELD SERVICE ENGINEER FSE INSPECTED THE UNIT AND REPLACED THE FIBER OPTIC CABLE. THE UNIT PASSED ALL REQUIRED CALIBRATIONS FUNCTIONAL CHECKS AND SAFETY TESTS IN ACCORDANCE WITH THE MANUFACTURERS SPECIFICATIONS AND WAS RETURNED TO SERVICE READY FOR PATIENT USE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS B4, G3, G6, H2, H11. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE PART FIBER OPTIC JUMPER WITH A REPORTED UNIT FAILURE OF KINKED FIBER OPTIC CABLE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE RECEIVED FIBER OPTIC JUMPER CABLE AND FOUND THAT THE CABLE SHOWS AN INDICATION OF MINOR KINKING. THE FAT DEPARTMENT INSTALLED THE FIBER OPTIC JUMPER IN THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED IT TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. FUNCTIONAL TESTING OF THE CABLE FAILED WITH A SINGLE COUNT OF 0 AND NO DETECTABLE FIBER OPTIC WAVEFORM OBSERVED DURING MEASUREMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS ABLE TO VERIFY THE FAILURE AS DESCRIBED BY THE CUSTOMER. THE PART IS BEING RETAINED IN THE FAT DEPARTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ERROR CODE 53. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17312 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