BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM98

    MDR report key: 3964291 · Received June 19, 2014

    Report

    Report Number
    2249723-2014-00725
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    February 3, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET (B)(4) REPORTED THAT DURING THE EVAL, THE COMPANY REP OBSERVED THAT THE POWER SWITCH WAS UNSTABLE. THE COMP REP REPLACED THE POWER SWITCH (PART NUMBER 0012-00-0834). DURING THE IABP EVAL, THE SAFETY RISK AND THE BATTERIES WERE REPLACED AS A PART OF PREVENTIVE MAINTENANCE. THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. NOTE: EVENT DATE AND SERIAL NUMBER WAS NOT AVAILABLE. REFER MDR 2249723-2011-00023, SUPPLEMENT 1 AND 2 (INTERNAL COMPLAINT #: P-11-00023) FOR THE FIRST PUMP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE IABP SHUTDOWN. SINCE THIS UNIT WAS USED AS A REPLACEMENT UNIT, IT WAS REPLACED BY THE EARLIER UNIT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360902 SYSTEM98 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP SYSTEM98

    Patients

    Seq Age Sex Outcome Treatment
    1