BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 7519460 · Received May 16, 2018

    Report

    Report Number
    2249723-2018-00839
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 26, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. GETINGE WAS NOT REQUESTED TO SERVICE THE IABP. HOWEVER, A NEW REMOVABLE POWER SUPPLY WAS SHIPPED TO THE CUSTOMER AS GOODWILL. THE FULL NAME OF THE EVENT SITE NOTED IS (B)(6) MEDICAL CENTER (TP).

    Additional Manufacturer Narrative · 1

    THE TRANSPORT POWER SUPPLY WAS REPLACED BY BIOMED AND THE IABP WAS CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) RESCUE POWER SUPPLY WAS NOT FUNCTIONAL, AND THAT THE POWER SUPPLY CORD WAS REPLACED LAST YEAR, BUT WAS BARELY USED AND WAS SITTING ON A SHELF. THE CIRCUMSTANCE UNDER WHICH THE EVENT OCCURRED IS UNKNOWN; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) RESCUE POWER SUPPLY WAS NOT FUNCTIONAL, AND THAT THE POWER SUPPLY CORD WAS REPLACED LAST YEAR, BUT WAS BARELY USED AND WAS SITTING ON A SHELF. THE CIRCUMSTANCE UNDER WHICH THE EVENT OCCURRED IS UNKNOWN; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363462 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1