BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 21430652 · Received February 21, 2025

    Report

    Report Number
    2249723-2025-0000808
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 1, 2025
    Report Date
    May 20, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON UPDATED INFORMATION, CUSTOMER MISREMEMBERED THE DEVICE INFORMATION SINCE MULTIPLE DEVICES OF THE SAME MODELS ARE AVAILABLE IN THE HOSPITAL . THE OTHER CARDIOSAVE WAS FAULTY AND CUSTOMER HAS FILED A NEW COMPLAINT. HENCE THIS EVENT DOES NOT MEET THE DEFINITION OF VALID COMPLAINT. NO ADDITIONAL REPORTS WILL BE SENT FOR THIS MFG REPORT NUMBER 2249723-2025-0000808. UPDATED FIELD- B4, G3, G6, H2, H11.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MADE AN ABNORMAL SOUND DURING USE, SMELLED A BURNING SMELL, AND AUTOMATICALLY SHUT DOWN. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706397 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown