BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20531402 · Received October 25, 2024

    Report

    Report Number
    2249723-2024-0004373
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 14, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND ALSO FOUND FAULT LOGS 77 IN THE RECENT FAULTS. THE FSE REPLACED SCROLL COMPRESSOR (0119-00-0236), MUFFLER <100 (0103-00-0499) AND MUFFLER 1/8 (0103-00-0631). AFTER FURTHER TESTING THE IABP THE UNIT ALSO FAILED THE PIM TEST. REPLACED PNEUMATIC MODULE (0997-00-1178) AND PIM TEST PASSED SUCCESSFULLY. PERFORMED A PM, FULL CALIBRATION, AND TESTED THE UNIT. THE PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING. RETURNED THE UNIT TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A POWER UP TEST FAILURE CODE 14. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092955 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 N/A.