BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 6761541 · Received August 2, 2017

    Report

    Report Number
    2249723-2017-00193
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    April 29, 2017
    Report Date
    October 16, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER GETINGE STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE COMPANY REPRESENTATIVE REPORTED THAT A NEW POWER SUPPLY HAS BEEN INSTALLED. POST POWER SUPPLY REPLACEMENT, FUNCTION TEST WAS CARRIED OUT SUCCESSFULLY AND THR IABP UNIT WAS IMMEDIATELY RETURNED TO CLINICAL SERVICE.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER GETINGE STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE COMPANY REPRESENTATIVE REPORTED THAT A NEW POWER SUPPLY HAS BEEN INSTALLED. GETINGE COMPANY ENGINEERS ARE INVESTIGATING THE FAILED PART TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC SUPPLY OF THE INTRA-AORTIC BALLOON PUMP (IABP) WAS FAILING TO WORK. THE FAILURE WAS NOTICED DURING TRANSPORT. THERE WAS NO PATIENT INVOLVEMENT; THUS NO ADVERSE EVENT WAS REPORTED. THE FAULT WAS IDENTIFIED ON THE SITE AND THE IABP UNIT WAS TAKEN OUT OF SERVICE. THE CUSTOMER REPORTED THAT THIS IS THE 2ND OCCURENCE OF A POWER SUPPLY FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC SUPPLY OF THE INTRA-AORTIC BALLOON PUMP (IABP) WAS FAILING TO WORK. THE FAILURE WAS NOTICED DURING TRANSPORT. THERE WAS NO PATIENT INVOLVEMENT; THUS NO ADVERSE EVENT WAS REPORTED. THE FAULT WAS IDENTIFIED ON THE SITE AND THE IABP UNIT WAS TAKEN OUT OF SERVICE. THE CUSTOMER REPORTED THAT THIS IS THE 2ND OCCURENCE OF A POWER SUPPLY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539580 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1