BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3871940 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00469
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    August 21, 2013
    Report Date
    August 21, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE FOUND THE SOURCE OF THE LOW AUDIO OUTPUT WITH THE PCB. THE IABP WAS PLACED OUT OF SERVICE UNTIL THE PCB (PART NUMBER 0670-00-788) WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE, THE COMPANY REPRESENTATIVE OBSERVED THAT THE IABP HAD VERY LOW AUDIO OUTPUT. THE SOUND WAS DISTORTED AND NO AUDIO LEVEL ADJUSTMENT WAS POSSIBLE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236123 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1