BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 4258519 · Received September 3, 2014

    Report

    Report Number
    2249723-2014-01290
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    April 26, 2013
    Report Date
    May 3, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE CABLE BETWEEN THE DISPLAY PANEL AND INVERTER PCB (PART NUMBER: 0012-00-1558). HE ALSO REPLACED THREE DIFFERENT LABELS (0334-00-1810, 0334-00-1809, 0334-00-1811 AND 0334-00-1810-01) THAT WERE DAMAGED WHEN DISASSEMBLING THE MONITOR. THE IAP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE SALES DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE WAVEFORM DISPLAY PANEL JITTERED AND FLASHED INTERMITTENTLY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537103 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1