BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4030583 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-00999
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP TESTED THE UNIT AND OBSERVED A BURNT TERMINAL ON THE PLUG (MALE END). THE COMPANY REP REPLACED AC LINE CORD ASSEMBLY (PART NUMBER 0012-00-0886-01) AND CORRECTED THE FAILURE. THE COMPANY REP PERFORMED FUNCTIONAL AND SAFETY TESTS. THE UNIT MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. THE POWER CORD WAS SENT TO (B)(4) REPAIR CENTER FOR EVALUATION. SUSTAINING ENGINEERING INSPECTED THE RETURNED LINE CORD AND FOUND THE GROUND AND LINE TERMINALS BENT. THE PROBABLE CAUSE WAS DETERMINED TO BE CUSTOMER ABUSE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE WITH A PT, THE AC PLUG SMOKED, THEN SPARKED IN THE PT ROOM. THE IABP WAS REPLACED AND THE THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442664 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1