BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20640632 · Received November 8, 2024

    Report

    Report Number
    2249723-2024-0004603
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 21, 2024
    Report Date
    April 7, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D8, D9, G1(CONTACT OFFICE, CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE WAS NOT ABLE TO REPRODUCE THE PROBLEM STATED BY CUSTOMER, BUT DID FIND FAULT #118 LOGGED. UPON FURTHER INSPECTION FSE FOUND THE ON/OFF BUZZER WOULD NOT SOUND WHEN TURNING THE UNIT ON AND OFF AND POWER FAILS ALARM WOULD NOT ALARM. FSE REPLACED THE BACKPLANE BOARD (D670-00-1163) AND DRIVE MANIFOLD ASSEMBLY (D104-00-0031). FSE ALSO FOUND THE TETHER ASSEMBLY TO BE BROKEN, AND THE FSE REPLACED THE TETHER ASSEMBLY (D997-00-0596). THE FSE THEN PERFORMED A FULL PM, BUT UNIT FAILED THE DRIVE MANIFOLD TEST. FSE REMOVED THE PNEUMATIC ASSEMBLY AND RESEATED ALL HOSES AND CONNECTIONS. RAN DRIVE MANIFOLD TEST, BUT UNIT FAILED ONCE AGAIN, SUSPECT A POSSIBLE DEFECTIVE NEW DRIVE MANIFOLD ASSEMBLY, NEW DRIVE MANIFOLD ASSEMBLY REMOVED AND REPLACED, UNIT PASSED BUT FAILED THE PIM LEAK TEST. FSE THEN REMOVED THE PNEUMATIC ASSEMBLY TO TROUBLESHOOT FURTHER AND FOUND THE PNEUMATIC MODULE TO BACK PLANE CABLE HARNESS TO BE DAMAGED WITH EXPOSED WIRES. FSE RETURNED WITH PNEUMATIC MODULE TO BACKPLANE CABLE ASSEMBLY. FSE DISASSEMBLED THE UNIT AND REPLACED (D012-00-1708) CABLE WIRE HARNESS. FSE FINALLY PERFORMED AN ALL MANIFOLD LEAK TEST AND UNIT PASSED WITH NO ISSUES. THE FSE PERFORMED A FULL PM AND THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.

    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 DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880140 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown