BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANDHILL SCIENTIFIC

    MDR report key: 10091552 · Received May 27, 2020

    Report

    Report Number
    10091552
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 29, 2020
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A 24HR ESOPHAGEAL IMPEDANCE PH CATHETER PLACED. HE WAS DUE TO RETURN FOR CATHETER REMOVAL AND STUDY DOWNLOAD ON THE FOLLOWING DAY AT 1400. HE CALLED ON THE MORNING OF THE PROCEDURE TO REPORT THAT THE MONITOR HAD STOPPED WORKING. PATIENT WAS ADVISED TO RETURN TO UNIT AT THAT TIME BUT DID NOT RETURN UNTIL THAT AFTERNOON. MOTILITY RN WAS NOT AVAILABLE TO REMOVE THE CATHETER AT THAT TIME. CATHETER WAS REMOVED BY ANOTHER ENDOSCOPY RN. MOTILITY RN ATTEMPTED TO DOWNLOAD STUDY UNSUCCESSFUL. SD CARD CONTAINING STUDY WAS MAILED TO DIVERSATEK HEALTH TO BE ANALYZED. THEY WERE NOT ABLE TO RETRIEVE STUDY. RECORD IS BEING SENT OUT FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554609 SANDHILL SCIENTIFIC SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE, INC. Z07-2000-B-B

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA