BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 22169794 · Received June 9, 2025

    Report

    Report Number
    2249723-2025-0002534
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 24, 2025
    Report Date
    September 8, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS : H6 ( MEDICAL DEVICE ¿ PROBLEM CODE). UPDATED FIELDS: B4,D8, D9, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE DEVICE AND FOUND MAINS CABLE PLUG TO BE FAULTY. FSE REPLACED WITH 13 AMP PLUG AS A TEMPORARY MEASURE AND WILL QUOTE FOR REPLACEMENT CABLE ASSY (D012-00-1823-04). NO SERVICE REPORT AS CUSTOMER IS FIXING THEMSELVES. THIS WILL BE COMPLETED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT HOLDING A CHARGE AND THE BATTERY BACK UP ISN'T CHARGING EITHER. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631282 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown