BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 20019638 · Received August 21, 2024

    Report

    Report Number
    2249723-2024-03416
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 7, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELDS: D4. A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THEY REPLACED THE HINGES (0105-00-0138-02, 0105-00-0138-01) AND HINGE COVERS (0380-00-0561). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING REGULAR ANNUAL MAINTENANCE, THE STIFFER MOVEMENT OF DISPLAY ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HINGES. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357948 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown