BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22383272 · Received July 2, 2025

    Report

    Report Number
    2249723-2025-0002833
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 18, 2025
    Report Date
    November 14, 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, B5, D9, E1 (INITIAL REPORTER, EVENT SITE EMAIL), E3, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (HEALTH EFFECT ¿ CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS ), H11. CORRECTED FIELDS: D10, H6 (MEDICAL DEVICE ¿ PROBLEM CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND COULD NOT DUPLICATE THE MULTIPLE GAS LOSS ALARMS DURING INSPECTION. DUE TO MULTIPLE CALL BACKS THE DRIVE MANIFOLD ASSEMBLY, TUBE ASSEMBLY FOR THE DRIVE MANIFOLD, DRIVE REGULATOR, MUFFLER TO RESERVOIR, AND FITTING MUFFLER WERE REPLACED (D104-00-0031, D354-00-0175, D103-00-0709, D103- 000626, D004-00-0091, D103-00-0633). IT WAS REPORTED THE CUSTOMER SWITCHED TO A DIFFERENT PUMP WHICH RESOLVED THE ISSUE INITIALLY. THE FIRST PUMP AFTER BEING SERVICED PASSED ALL FUNCTIONAL TEST AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE FIRST PUMP WAS CLEARED FOR CLINICAL USE AS WELL. NO PATIENT HARM OR INJURY REPORTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD A GAS LOSS IN IAB CIRCUIT ALARM AND A CONDENSATION MALFUNCTION. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCING MULTIPLE GAS LOSS - CONDENSATION IN THE LINE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176514 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 UNKNOWN.