BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTRAC PH-Z PRECISION REFLUX MONITORING

    MDR report key: 1558295 · Received December 8, 2009

    Report

    Report Number
    MW5013881
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 8, 2009
    Manufacturer
    SIERRA SCIENTIFIC INSTRUMENTS, INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STUDY INITIATED IN 2009. PROBE CALIBRATED NORMALLY AND RECORDER SET TO RECORD WHEN PATIENT LEFT. PATENT RETURNED THE FOLLOWING DAY, FOR PROBE REMOVAL. WHEN THE RECORDER WAS CONNECTED TO THE COMPUTER, IT HAD NO DATA TO UPLOAD. EVENTS HAD BEEN WRITTEN ON A DIARY KEPT BY THE PATIENT. THE PATIENT WAS TOLD TO USE TIME DISPLAYED ON THE RECORDER TO DOCUMENT ON THE DIARY. PHYSICIAN WAS NOTIFIED AND PATIENT WAS NOTIFIED. WE HAVE HAD PROBLEMS PREVIOUSLY WITH THE PH RECORDERS AND SIERRA SCIENTIFIC REPLACED BOTH OF THEM. THIS PROBE CALIBRATED NORMALLY PRIOR TO USE; HOWEVER, ANOTHER RECORDER WAS REPORTED TO HAVE TURNED OFF THREE TIMES WHILE THE PATIENT HAD IT IN USE, AND SHE HAD TO TURN IT BACK ON. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TO DIAGNOSE REFLUX. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTRAC PH-Z PRECISION REFLUX MONITORING 24 HOUR PH MONITOR FFT SIERRA SCIENTIFIC INSTRUMENTS, INC. ACCUTRAC PH-Z
    2 ACCUTRAC PH-Z PRECISION REFLUX MONITORING 24 HOUR PH MONITOR FFT SIERRA SCIENTIFIC INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other