BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16271992 · Received January 31, 2023

    Report

    Report Number
    2249723-2023-00727
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    April 11, 2021
    Report Date
    January 12, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE IABP UNIT AND RESOLVED THE ISSUE BY REPLACING THE ENTIRE CART ASSEMBLY (0997-00-1179) (0040-00-0458-12) (0040-00-0458-11) AS IT WAS AN OLD VERSION CART, AS WELL AS UPGRADED NEW VERSION AC REEL ASSEMBLY (0012-00-1688-21). THE FSE THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET 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 TRANSPORT THE AMBULANCE EMS TEAM DAMAGED THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CONSOLE AND BROKE OFF ONE OF THE WHEELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052288 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN.