BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAPPER PH-Z VERSAFLEX CATHETER

    MDR report key: 7536784 · Received May 23, 2018

    Report

    Report Number
    7536784
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 15, 2018
    Manufacturer
    MEDTRONIC INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR MANOMETRY WITH IMPEDANCE CATHETER PLACEMENT. WHILE CALIBRATING IMPEDANCE RECORDER, RECORDER SHUT OFF WHILE INPUTTING PATIENT'S MEDICAL RECORD NUMBER. BATTERIES WERE REMOVED AND REPLACED. IMPEDANCE RECORDER CAME BACK ON WITHOUT ANY ISSUE. CALIBRATED CATHETER WITHOUT ANY ISSUE. CATHETER PLACED AND RECORDER VERIFIED TO BE WORKING BEFORE PATIENT DISCHARGE. PATIENT CALLED BACK APPROXIMATELY 45 MINUTES AFTER DISCHARGE AND SAID THAT THE RECORDER WAS NOT ILLUMINATING WHEN BUTTON WAS PUSHED FOR MEAL START. PATIENT RETURNED FOLLOWING DAY AND THE RECORDER WAS UPLOADED. NO INFORMATION HAD BEEN RECORDED. SEVERAL OF THESE DIGITRAPPER PH-2 MONITORS LOST BATTERY POWER SOON AFTER THE PATIENT WAS RELEASED FROM THE PROCEDURE AREA. THIS WAS DUE TO THE WRONG TYPE OF BATTERY BEING PLACED INTO THE MONITOR. THE MONITOR REQUIRES ALKALINE BATTERIES AND LITHIUM WERE BEING USED. I HAVE A ROUGH ESTIMATE OF THIS HAPPENING 5 TIMES BEFORE OUR STAFF WAS ABLE TO FIGURE OUT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379098 DIGITRAPPER PH-Z VERSAFLEX CATHETER PH PROBE FFT MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT KNOWN.