BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21803120 · Received April 9, 2025

    Report

    Report Number
    2249723-2025-0001670
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 27, 2025
    Report Date
    October 8, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, E3, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) STATES, FSE IS AWAITING A QUOTE AND A WAY TO PROCEED FROM DEMO RENTAL. FSE NEEDS TO REPLACE CABLE COIL CORD (0012-00-1839), KITB CARDIOSAVE TOP COVER INSTALLATION (0040-00-0454) AND COVER CART TOP (0380-00-0541). THIS IS A CUSTOMER ABUSE OF UNIT QUOTE AND THEY WILL PAY FOR REPAIRS. NO REPAIR INFORMATION AVAILABLE. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD DAMAGED COILED CORD AND CHASSIS AS THE DEVICE WAS DROPPED WHILE CARRYING IT ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816867 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

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