BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22034008 · Received May 16, 2025

    Report

    Report Number
    2249723-2025-0002238
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 2, 2025
    Report Date
    September 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION IN BLOCK E1: EVENT SITE ADDRESS: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: E1 (EVENT SITE NAME, EVENT SITE ADDRESS, EVENT SITE EMAIL). UPDATED FIELDS: B4, B5, B6, B7, D10, D9, G1 (CONTACT PERSON ¿ MFG SITE), G2, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE, HEALTH EFFECT ¿ CLINICAL CODE, HEALTH EFFECT ¿ IMPACT CODES, MEDICAL DEVICE ¿ PROBLEM CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) STATED THE FAILURE WAS NOTICED DURING A PREVENTATIVE MAINTENANCE AND THE CUSTOMER APPARENTLY LENT THEIR DEVICE TO THE (B)(6) HOSPITAL, WHERE THE CARDIOSAVE WAS UNFORTUNATELY DAMAGED FOLLOWING A FALL. AFTER EVALUATION THE FSE FOUND A HELIUM LEAK ON THE DEVICE AND THE DRIVE MALFUNCTIONED. THE FSE REPORTED THAT USERS AT THE (B)(6) CLINIC DROPPED THE CARDIOSAVE. THE FSE REPLACED BROKEN COVER AND CHASSIS (0441-00-0194), HANDLE (00367-00-0114) WITH SCREWS (0212-12-0604 & 0212-12-0605), DRIVE MANIFOLD (0104-00-0031), HELIUM TANK ASSY (0997-00-0565) AND FULL FUNCTIONAL CHECKS WERE PERFORMED. ALL FUNCTIONAL AND SAFETY TEST WERE GOOD.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY A GETINGE FIELD SERVICE ENGINEER (FSE) THAT WHILE THE DEVICE WAS BEING MOVED FROM SERVICE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS DROPPED WITHOUT THE PATIENT BEING CONNECTED TO IT. THE FSE STATED THE FAILURE WAS NOTICED DURING A PREVENTATIVE MAINTENANCE AND THE CUSTOMER APPARENTLY LENT THEIR DEVICE TO THE TARBES HOSPITAL, WHERE THE CARDIOSAVE WAS UNFORTUNATELY DAMAGED FOLLOWING A FALL. AFTER EVALUATION THE FSE FOUND A HELIUM LEAK ON THE DEVICE AND THE DRIVE MALFUNCTIONED AND BROKEN COVER. THE FSE REPLACED BROKEN COVER AND CHASSIS, HANDLE WITH SCREWS, DRIVE MANIFOLD, HELIUM TANK ASSY AND FULL FUNCTIONAL CHECKS WERE PERFORMED. ALL FUNCTIONAL AND SAFETY TEST WERE GOOD. NO PATIENT INVOLVED AND HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE TECHNICIAN THAT USERS AT THE ORMEAU CLINIC DROPPED CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PM, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP HAD A HELIUM LEAK, DRIVE MALFUNCTION AND ALSO HAVE A BROKEN COVER. THE FSE ALSO REPORTED THAT USER DROPPED THE DEVICE. THERE WAS NO PATIENT INVOLVED AND NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217023 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.| UNKNOWN.