BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21155600 · Received January 15, 2025

    Report

    Report Number
    2249723-2025-0000206
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 26, 2024
    Report Date
    April 30, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4. G1, G3, G6, H2, H11. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT IS NOT REPORTABLE TO US. SINCE IT WAS USER ERROR, HENCE SENDING DOWNGRADED MDR. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000206 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    UPDATE FIELDS: B4, B5, E1 (INITIAL REPORTER NAME, EMAIL, CONTACT DETAILS), G1, G3, G6, H2, H11 A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SHORT BATTERY RUN TIME. NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DURING USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SHORT BATTERY RUN TIME. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855229 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