BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20085280 · Received August 28, 2024

    Report

    Report Number
    2249723-2024-03507
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 11, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: B4, D9, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT, INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE STATED THAT THE CUSTOMER DID NOT PROPERLY SECURE THE DISPLAY TO POP-UP MOUNT DURING TRANSPORT. AS A RESULT, THE DISPLAY FELL OFF AND WAS DAMAGED. THE FSE REPLACED THE UPPER DISPLAY BEZEL (0380-00-0559), THE RIGHT DISPLAY HINGE (0105-00-0138-02), THE LEFT DISPLAY HINGE (0105-00-0138-01), AND THE LCD UPPER BRACKET FRAME (0406-00-0894). THE FSE PERFORMED FUNCTIONAL, ELECTRICAL, AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS DROPPED. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE EN ROUTE TO HELICOPTER BEFORE PATIENT WAS PICKED UP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS DROPPED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158587 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 NA Unknown