BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17349758 · Received July 19, 2023

    Report

    Report Number
    2249723-2023-03244
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    July 6, 2023
    Report Date
    April 12, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6, H10. THE GETINGE SERVICE TERRITORY MANAGER (STM) REPORTED THAT THEY REPLACED TOP COVER AND LABELS. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0040-00-0457 SN: N/A DISPLAY TOP COVER. PN: 0334-00-1809 SN: N/A UPPER LABEL. PN: 0334-00-1810-01 SN: N/A LABEL ID. PN: 0040-00-0457 WAS RECEIVED WITH A REPORTED FAILURE OF THE DISPLAY TOP COVER CRACKED. NO LISTED FAILURES FOR THE OTHER PARTS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND: PN: 0334-00-1809 HAS A THIN CRACK IN THE OUTER AREA OF THE COVER. PN: 0334-00-1810-01 AND PN: 0334-00-1810-01 WERE DAMAGED. FAT VERIFIED THE LISTED FAILURE. RETAINING THE IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS DISPLAY TOP COVER CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025018 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

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