BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21262625 · Received January 29, 2025

    Report

    Report Number
    2249723-2025-0000408
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 9, 2025
    Report Date
    March 19, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- INITIAL REPORTER- (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G1, G3, G6, H2, H11. THE COMPLAINT RECORD IS DOWNGRADED BASED ON THE FOLLOW-UP INFORMATION. SINCE BATTERY WAS DUE FOR REPLACEMENT, HENCE THIS COMPLAINT IS NOT VALID AND RECORD NEEDS TO BE CANCELLED. NO ADDITIONAL REPORTS WILL BE SENT FOR THIS MFG REPORT NUMBER 2249723-2025-0000408.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BATTERY OF CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS DETERIORATED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509951 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.