BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21872116 · Received April 21, 2025

    Report

    Report Number
    2249723-2025-0001840
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 31, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: B5.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, HELIUM ASSEMBLY FAILED DURING TESTING AND REPLACED O-RING BUNA (0354-00-02028) AND BATTERY (0146-00-0146).

    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,INVESTIGATION CONCLUSIONS),H11. CORRECTED FIELDS: E2. NO FURTHER INFORMATION IS AVAILABLE COMPLAINT WILL BE CLOSED AND IN THE EVENT NEW INFORMATION WAS TO BECOME AVAILABLE, THIS RECORD WILL BE REOPENED AND UPDATED. NO SERVICE ORDER AVAILABLE AND THERE IS NO RELEVANT REPAIR INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT AUGMENTING AND STAYING IN STANDBY MODE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ISSUE WITH AUGMENTATION DURING STANDBY MODE. THERE WAS NO PATIENT INVOLVED AND HARM OCCURRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337867 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