BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS PUMP

    MDR report key: 1061913 · Received June 16, 2008

    Report

    Report Number
    1221934-2008-00308
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Report Date
    May 2, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS, AT THIS POINT IN TIME, AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING AN EVAL. UPON COMPLETION OF THE INVESTIGATION, THE RESULTING CONCLUSIONS WILL BE THE SUBJECT MATTER OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE ECG SIGNAL IS DISTORTED WHILE THE PUMP IS IN OPERATION. THE NUMERICAL DISPLAY ON BPM MACHINE WOULD JUMP FROM 50 TO 100. THERE ARE 5 PUMPS AT THE FACILITY AND THEY DO NOT KNOW WHICH ONE OF THEM MAY BE THE PUMP IN QUESTION. THERE WAS NO PT CONSEQUENCE. ALSO SEE ASSOCIATED MDRS 1221934-2008-00307, 1221934-2008-00309, 1221934-2008-00310 AND 1221934-2008-00311.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FMS PUMP FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK 284590 0709F1479

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK