BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 8149126 · Received December 10, 2018

    Report

    Report Number
    2249723-2018-02137
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 16, 2018
    Report Date
    February 4, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) OF THE INTRA-AORTIC BALLOON PUMP (IABP) INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE PRODUCTION DHR RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INCOMING INSPECTION ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE GETINGE REP FOUND FILLING ERROR OF HELIUM GAS. THEY ALSO FOUND A BREAKAGE OF O-RING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS WAS AN OUT-OF-BOX FAILURE.

    Additional Manufacturer Narrative · 1

    A GETINGE SERVICE REPRESENTATIVE EVALUATED THE IABP UNIT AND REPLACED AN O-RING TO CORRECT THE FAILURE. THE IABP PASSED ALL TESTING AND RETURNED TO THE GETINGE WAREHOUSE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INCOMING INSPECTION ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE GETINGE REP FOUND FILLING ERROR OF HELIUM GAS. THEY ALSO FOUND A BREAKAGE OF O-RING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS WAS AN OUT-OF-BOX FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986102 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1