BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHR

    MDR report key: 20146779 · Received September 5, 2024

    Report

    Report Number
    2023374-2024-00001
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    May 16, 2024
    Report Date
    August 28, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFX
    UDI-DI
    00816734022177
    PMA / PMN Number
    K012232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID NOT CONTACT THE MANUFACTURER PRIOR TO FILING A MEDWATCH REPORT WITH FDA (UF/IMPORTER REPORT (B)(4). WHILE THE MALFUNCTION REPORTED BY THE USER FACILITY DOES NOT MEET THE CRITERIA FOR MANDATORY REPORTING, THE MANUFACTURER IS FILING THIS REPORT IN RESPONSE TO THE USER FACILITY REPORT. THE USER FACILITY REPORT STATED: "THE IMPEDANCE MACHINE WOULD NOT FUNCTION, AND REGISTERED NURSE (RN) DID NOT HAVE A REPLACEMENT MACHINE TO USE, SO THE IMPEDANCE CATHETER WAS NOT PLACED AS PLANNED. VENDOR WAS CALLED TO LET THEM KNOW THAT THE MACHINE NEEDS REPAIRED." A REVIEW OF ALL COMPLAINT RECORDS SHOWED THIS CUSTOMER DID NOT REPORT THIS EVENT TO THE DIVERSATEK HEALTHCARE. CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION BUT NONE WAS PROVIDED. THE FIRST STEP FOR USE OF THE ZEPHR REFLUX MONITORING SYSTEM IS TO TURN IT ON THE RECORDER AND CONNECT IT TO A DISPOSABLE REFLUX PROBE OUTSIDE THE PATIENT. CALIBRATION OF THE PROBE IS THEN PERFORMED OUTSIDE OF THE PATIENT. IF THE USER COULD NOT INITIATE USE OF THE ZEPHR RECORDER UNIT, A PATIENT WAS NOT INVOLVED IN THIS EVENT. THEREFORE, IT IS UNKNOWN WHY THIS WAS REPORTED AS IT DOES NOT MEET THE THRESHOLD FOR A REPORTABLE EVENT. ADDITIONALLY, IF THE ZEPHR WERE TO FAIL DURING A REFLUX STUDY, IT WOULD POSE NO SAFETY RISK TO THE PATIENT. BASED ON A REVIEW OF TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE DEVICE DOES NOT POSE A SAFETY RISK EVEN IF USE CANNOT BE INITIATED. ADDITIONALLY, PATIENT INVOLVEMENT BEGINS AFTER THE ZEPHR HAS BEEN STARTED, SO THE INABILITY TO INITIATE USE WOULD NEVER INVOLVE A PATIENT. THIS DEVICE IS APPROXIMATELY 11 YEARS OLD AND REPAIRS TO UNITS OF THAT AGE ARE NOT UNCOMMON. DIVERSATEK HEALTHCARE HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    CUSTOMER USER FACILITY REPORT CONTAINED THE FOLLOWING INFORMATION: DESCRIBE THE EVENT OR PROBLEM: THE IMPEDANCE MACHINE WOULD NOT FUNCTION, AND REGISTERED NURSE (RN) DID NOT HAVE A REPLACEMENT MACHINE TO USE, SO THE IMPEDANCE CATHETER WAS NOT PLACED AS PLANNED. VENDOR WAS CALLED TO LET THEM KNOW THAT THE MACHINE NEEDS REPAIRED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? UPPER GASTROINTESTINAL ENDOSCOPY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887182 ZEPHR SYSTEM, GASTROINTESTINAL MOTILITY FFX DIVERSATEK HEALTHCARE Z07-2000-B-B N/A 00816734022177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown