BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 16096672 · Received January 4, 2023

    Report

    Report Number
    2249723-2023-00058
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 19, 2022
    Report Date
    March 18, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    ADDITIONAL INFORMATION: E1 (EVENT POSTAL CODE: (B)(4) , EVENT SITE STATE: LO). A GETINGE FIELD SERVICE ENGINEER FSE WAS DISPATCHED TO THE SITE TO EVALUATE THE UNIT. HE STATES THE CABLE DRUM REPLACED. ALL FUNCTIONAL AND CALIBRATION TESTS PASSED OK. NO PATIENT HARM OR OTHER DETAILS AVAILABLE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION.PERFORMED FUNCTIONAL TESTING WITH A MULTIMETER CONTINUITY TEST AND ALSO BY RETRACTING THE CABLE. NO ISSUES FOUND.FAT COULD NOT VERIFY THE REPORTED FAILURE OF THE CABLE REEL NOT RETRACTING.RETAINING THE IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4) REV. AP.THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS CABLE REEL IS NOT RETRACTING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909277 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown