BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3871950 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00463
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    September 23, 2013
    Report Date
    September 23, 2013
    Manufacturer
    DATASCOPE CORP.
    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 COMPANY REPRESENTATIVE FOUND THAT THE POWER SUPPLY MONITOR WAS NOT WORKING AND THE UNIT FAILING REGULATOR CALIBRATION. REPLACED POWER SUPPLY MONITOR (PART NUMBER: 0670-00-0821) AND SCROLL COMPRESSOR (PART NUMBER: 0119-00-0179). THE IABP WAS TESTED PER MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE IABP WAS NOT CHARGING THE BATTERIES. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236600 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1