BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 18934099 · Received March 19, 2024

    Report

    Report Number
    2249723-2024-01169
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    March 11, 2024
    Report Date
    August 25, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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

    THE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE APPLIED GREASE TO THE SAFETY DISK. THE FSE RAN A PIM LEAK TEST WHICH PASSED WITH NO ISSUES. THE FSE PERFORMED ALL FUNCTIONAL CHECKS AND CALIBRATIONS PER MANUFACTURER SPECIFICATIONS. THE IABP WAS THEN READY FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H6 (TYPE OF INVESTIGATION), H11 CORRECTED FIELDS: B5, H6 (MEDICAL DEVICE PROBLEM CODE AND INVESTIGATION CONCLUSIONS) H4 (MANUFACTURE DATE) SHOULD BE LEFT BLANK. KINDLY REVERT. THE FSE THAT ENCOUNTERED THE ISSUE APPLIED GREASE TO THE SAFETY DISK. THE FSE RAN A PIM LEAK TEST WHICH PASSED WITH NO ISSUES. THE FSE ALSO ADJUSTED THE CABLE SO IT BECAME UNSTUCK. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PRE-CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NUH RP PNEUMATIC INTERFACE MODULE (PIM) TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE USE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED THE PIM TEST AND THE POWER CORD WAS UNABLE TO RETRACT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561004 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown