BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4000 SOFTRANS IUPC

    MDR report key: 298919 · Received October 2, 2000

    Report

    Report Number
    MW1020057
    Event Type
    Malfunction
    Date Received
    October 2, 2000
    Date of Event
    September 16, 2000
    Report Date
    September 25, 2000
    Manufacturer
    KENDALL LTP
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/13/00: MFR IS NOT ABLE TO DETERMINE A ROOT CAUSE FOR THE BASELINE ISSUES EXPERIENCED BY HOSP. MFR NOTES THAT NO SUBSEQUENT ISSUES WERE ENCOUNTERED. THIS SUPPORTS THE POSITION THAT IMPROPER ZEROING OR REZEROING TECHNIQUE MAY HAVE CONTRIBUTED TO THE BASELINE ISSUE. DEVICES WERE NOT RETURNED TO MFR. THE DEVICES MAY NOT BE USED IN A PT FOR MORE THAN 24 HRS, SO IT IS PROBABLE THAT THE DEVICES WERE DISPOSED OF.

    Description of Event or Problem · 1

    ON TWO DIFFERENT PTS, THE INTRAUTERINE PRESSURE CATHETER PROVIDED QUESTIONABLE VARYING AND FALSE READINGS ON THE EFM. FOR ONE PT THE RESTING TONE SHOULD HAVE BEEN AT 15-20 MM/HG. THE INTRAUTERINE PRESSURE CATHETER USED SHOWED 40MM/HG. THE PT'S UTERUS FELT SOFT DURING THIS TIME. ACTION WAS TAKEN TO CHANGE INTRAUTERINE PRESSURE CATHETER, REZERO AND CHECK CONNECTIONS.

    Description of Event or Problem · 2

    ON TWO DIFFERENT PTS, THE INTRAUTERINE PRESSURE CATHETER PROVIDED QUESTIONABLE VARYING AND FALSE READINGS ON THE EFM. FOR ONE PT THE RESTING TONE SHOULD HAVE BEEN AT 15-20 MM/HG. THE INTRAUTERINE PRESSURE CATHETER USED SHOWED 40MM/HG. THE PT'S UTERUS FELT SOFT DURING THIS TIME. ACTION WAS TAKEN TO CHANGE INTRAUTERINE PRESSURE CATHETER, REZERO AND CHECK CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4000 SOFTRANS IUPC INTRAUTERINE PRESSURE MONITORING SYSTEM KXO KENDALL LTP * 010279

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other
    2 21 YR Other