BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 14274200 · Received May 4, 2022

    Report

    Report Number
    2249723-2022-01002
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Report Date
    March 26, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION NOT YET DETERMINED: ADDITIONAL INFORMATION IS BEING REQUESTED IN REGARDS TO WHETHER OR NOT THE CUSTOMER HAS REQUESTED FOR GETINGE TO SERVICE THE IABP UNIT INVOLVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (SITE COUNTRY), E2, E3, G3, G6, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10, H11 CORRECTED FIELDS: B5, D9, H3, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, HEALTH EFFECT ¿ IMPACT CODES) ADDITIONAL INFORMATION: EVENT SITE POSTAL CODE: LE3 9QP A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THE EQUIPMENT TO HAVE A FAULTY PRESSURE TRANSDUCER ADAPTOR CABLE. PART HAS BEEN REMOVED/REPLACED AND PUT THROUGH FIBRE OPTIC TEST TO TEST NEW ADAPTOR CABLE. ALL TESTS PASSED - EQUIPMENT HAS BEEN RETURNED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD VARIOUS FAULTS. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING RECENT SERVICE THE EQUIPMENT WAS FOUND TO HAVE A FAULTY PRESSURE TRANSDUCER ADAPTOR CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183774 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 N/A 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown