BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22217223 · Received June 17, 2025

    Report

    Report Number
    2249723-2025-0002620
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DUE TO CHARACTERIZATION LIMIT E1 (INITIAL REPORTER: GETINGE USA SALES LLC). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION IN BLOCK E1. E1 EVENT SITE ADDRESS IS (B)(6). E1 INITIAL REPORTER IS (B)(6). UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELD : E1 ( INITIAL REPORTER , EVENT SITE EMAIL , EVENT SITE ADDRESS, EVENT SITE NAME ), H6 ( MEDICAL DEVICE ¿ PROBLEM CODE ),

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D9, G1, G3, G6, H2, H3, H6 (HEALTH EFFECT CLINICAL CODE, HEALTH EFFECT IMPACT CODE, (COMPONENT CODE, INVESTIGATION FINDINGS , INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, ISOLATED FAILURE TO POWER INVERTER IN UPPER DISPLAY. REPLACED VIDEO GENERATOR AND POWER INVERTER PCB . PERFORMED FUNCTIONAL CHECK AND SAFETY TEST. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP MONITOR OF CARDIOSAVE IABP (INTRA-AORTIC BALLOON PUMP) WAS NOT WORKING- SHOWING A BUNCH OF LINES.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOP MONITOR OF CARDIOSAVE IABP (INTRA-AORTIC BALLOON PUMP) WAS NOT WORKING- SHOWING A BUNCH OF LINES. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502781 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