BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16269235 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00814
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    December 9, 2020
    Report Date
    January 11, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. UPON EVALUATING THE UNIT, THE FSE OBSERVED THE REPORTED ISSUE. HOWEVER, THE GETINGE FIELD SERVICE ENGINEER (FSE) ADVISED THAT THE CUSTOMER'S BIOMED TECHNICIAN PERFORMED SERVICE REPAIRS TO THE UNIT INVOLVED IN THIS REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION AT THIS TIME, THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE SUPPORT, DISPLAY MOUNT (0426-00-0098) AND SCREWS (0212-12-0605) X 4. THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS MISSING CONSOLE SUPPORT SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872897 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 Unknown N/A.