BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16233114 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00367
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 11, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D9, E1 (SITE COUNTRY), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSION), H10 ADDITIONAL INFORMATION: E1(EVENT SITE TELEPHONE: +011(066)898-951-719) A GETINGE FIELD SERVICE ENGINEER (FSE) FAILED TO CHECK THE DRIVE REGULATOR CALIBRATIONS, CAUSING THE ABOVE PROBLEM. FSE CHANGES VACUUM INLET (SM1) 2 PIECES FILTER (D103-00-0631) AND PRESSURE RESERVOIR (SM4) 1 PIECE FILTER (D103-00-0499) WHICH IS AN UNUSED SPARE PART FROM V014. AFTER CHANGING THE FILTER AND DOING DRIVE REGULATOR CALIBRATIONS AGAIN, TEST THE USE OF MACHINE, MACHINE CAN BE USED NORMALLY. IT WAS FURTHER DISCOVERED THAT THE SAFETY DISC AND BATTERY WERE DUE FOR REPLACEMENT. A PRICE WILL BE OFFERED LATER TO PURCHASE A NEW REPLACEMENT. UNIT RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A MESSAGE ON DISPLAY IABP MAY REQUIRE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A MESSAGE ON DISPLAY IABP MAY REQUIRE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033333 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown