BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 21216031 · Received January 23, 2025

    Report

    Report Number
    2249723-2025-0000327
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0000303. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0000303 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT RECORD IS DOWNGRADED BASED ON THE FOLLOW-UP INFORMATION. THE PARENT COMPLAINT IS DUPLICATE OF TRACKWISE RECORD (B)(4) HENCE NEED TO CANCEL THIS RECORD. NO ADDITIONAL REPORTS WILL BE SENT FOR THIS MFG REPORT NUMBER 2249723-2025-0000327.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) PUMP WOULD NOT TURN ON. IT WAS "CIRCLING" BUT WOULD NOT TURN ON FULLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931433 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 N/A.