BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98

    MDR report key: 3817547 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00264
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE PCB MOTOR CONTROLLER (PART NUMBER: D671-00-0004) AND THE HYDRAULIC COMPONENT PUMP ASSEMBLY DC KNF (PART NUMBER D102-00-0001). IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, AT POWER UP, IABP GENERATED AN "ELECTRICAL TEST FAILURE CODE# 50" (MOTOR SPEED OUT OF SPECIFICATION) AND SHUT DOWN. THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185443 SYSTEM 98 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYS98XT

    Patients

    Seq Age Sex Outcome Treatment
    1