BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 17200301 · Received June 26, 2023

    Report

    Report Number
    2249723-2023-02937
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 16, 2023
    Report Date
    April 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: D4 (UNIQUE IDENTIFIER (VERSION OR MODEL #, CATALOG #, UNIQUE IDENTIFIER (UDI) #). ADDITIONAL CONTACT NUMBER: (B)(6). INFORMATION WAS TAKEN FOR A COMPLAINT FOR BOTH THE PUMP AND THE TRAINER AND WILL BE FILED. TECH SUPPORT WILL BE NOTIFIED VIA EMAIL. THERESA IS THE EDUCATION DIRECTOR FOR SURVIVAL FLIGHT INC. THE PUMP IS LOCATED AT THE FLIGHT TEAM FACILITY. THEY ARE WITH THE WITHE RIVER MEDICAL HEALTH SYSTEM IN BATESVILLE ARKANSAS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP)UNIT HAS PRESSURE RELATED MALFUNCTION . THE EDUCATION DIRECTOR CALLED FOR HELP WITH HER CARDIOSAVE TRAINER WHILE PREPARING TO TEACH A BALLOON PUMP CLASS. SHE WAS UNABLE TO GET AN ALINE PRESSURE TRACING ON THE PUMP THROUGH THE TRAINER. THERE WAS NO OTHER PUMP TO TRY. SHE IS UNSURE IF THE ISSUE IS RELATED TO THE PUMP OR THE TRAINER AND NEEDED ASSISTANCE . THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR THE IABP, THE TRAINER IS BEING REPORTED SEPARATELY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221107 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

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