BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS98XT

    MDR report key: 4004888 · Received July 23, 2014

    Report

    Report Number
    2249723-2014-01013
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. AS A PRECAUTIONARY MEASURE, THE COMPANY REPRESENTATIVE REPLACED THE PRESSURE AND ECG CABLE ASSEMBLY (PART NUMBERS 0012-00-0976 AND 0012-00-0977). IN UNRELATED REPAIRS, THE IV POLE COLLAR (PN/ 0105-00-0114) AND DOPPLER TETHER ASSEMBLY (P/NS 0334-00-2608-01 AND 0997-00-0406) WERE ALSO REPLACED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING INITIAL SET UP ON THE PATIENT, THEY WERE UNABLE TO ZERO PRESSURE ON THE IABP. THE CUSTOMER REPLACED THE PUMP AND CONTINUED THERAPY. THIS EVENT OCCURRED WITH THE PUMP FOR SEVERAL PATIENTS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430028 SYS98XT INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYS98XT

    Patients

    Seq Age Sex Outcome Treatment
    1