BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 20255275 · Received September 19, 2024

    Report

    Report Number
    2249723-2024-0003836
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 29, 2024
    Report Date
    March 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D8,D9,G1(CONTACT PERSON ¿ MFG SITE),G3,G6,H2,H3.H6(TYPE OF INVESTIGATION,INVESTIGATION FINDINGS,INVESTIGATION CONCLUSIONS,COMPONENT CODES),H11 THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE UPPER DISPLAY HINGE COVER, THE DISPLAY TOP COVER ASSEMBLY, AND LABELS. THE FSE STATED THAT THE DAMAGE WAS DUE TO CUSTOMER ABUSE OF THE UNIT. THE FSE COMPLETED THE PM. ALL TESTS WERE RAN AND IN ACCORDANCE TO THE MANUFACTURER'S SPECIFICATIONS. THE IABP WAS CLEARED FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0040-00-0457 QTY: 2 PN 0380-00-0561 QTY: 4 PN 0334-00-1809 PN 0334-00-1810-01 THE FAT PERFORMED A VISUAL INSPECTION AND FOUND 2 OF THE PN 0040-00-0457 TO HAVE CRACKS ON IT. 2 OF THE PN 0380-00-0561 WERE DAMAGED. THE REST OF THE PARTS WERE IN GOOD CONDITION. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AS.THE ROOT CAUSE OF THE DAMAGED PARTS IS USER ERROR DUE TO PHYSICAL ABUSE OF THE UNIT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747323 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