BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERSATEK HEALTHCARE

    MDR report key: 20518166 · Received October 23, 2024

    Report

    Report Number
    2023374-2024-00002
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 23, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFT
    UDI-DI
    00816734022252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID CONTACT THE MANUFACTURER ON 01 JULY 2024 PRIOR TO FILING A MEDWATCH REPORT WITH FDA (UF/IMPORTER REPORT # (B)(4)). HOWEVER, BECAUSE THE MALFUNCTION REPORTED BY THE USER FACILITY DID NOT MEET THE CRITERIA FOR MANDATORY REPORTING, THE MANUFACTURER DID NOT FILE A REPORT WITH FDA AT THAT TIME. THIS REPORT IS IN RESPONSE TO THE USER FACILITY REPORT SENT TO THE FDA AND RECEIVED BY THE MANUFACTURER ON 25 SEP 2024. THE USER FACILITY REPORT STATED: "PATIENT WAS HAVING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) AND PLACEMENT OF 24-HOUR IMPEDANCE PH CATHETER. WHEN CALIBRATING THE CATHETER PRIOR TO PLACEMENT, AN IMPEDANCE ERROR MESSAGE APPEARED ON THE RECORDER. TRIED MULTIPLE CATHETERS AND DIFFERENT RECORDERS. ALL HAD THE SAME ERROR MESSAGE." THE FIRST STEP FOR USE OF THE ZEPHR REFLUX PROBES IS TO CONNECT THEM TO THE REUSABLE RECORDER AND PERFORM CALIBRATION. CALIBRATION OF THE PROBE IS PERFORMED OUTSIDE OF THE PATIENT AND WITHOUT PATIENT INVOLVEMENT. THIS ERROR MESSAGE MEANS CALIBRATION COULD NOT BE COMPLETED. IF THE USER COULD NOT CALIBRATE THE DISPOSABLE PROBE, 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 DISPOSABLE ZEPHR PROBE WERE TO FAIL DURING A REFLUX STUDY, IT WOULD POSE NO SAFETY RISK TO THE PATIENT. A REVIEW OF ALL COMPLAINT RECORDS SHOWED THIS LOT DID NOT HAVE ANY OTHER REPORTED ISSUES TO DIVERSATEK HEALTHCARE. BASED ON A REVIEW OF TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE DEVICE DOES NOT POSE A SAFETY RISK EVEN IF CALIBRATION COULD NOT BE PERFORMED. ADDITIONALLY, PATIENT INVOLVEMENT BEGINS AFTER CALIBRATION IS COMPLETED, SO THE INABILITY TO INITIATE USE WOULD NEVER INVOLVE A PATIENT. 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

    PER USER FACILITY REPORT (B)(4): DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS HAVING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) AND PLACEMENT OF 24-HOUR IMPEDANCE PH CATHETER. WHEN CALIBRATING THE CATHETER PRIOR TO PLACEMENT, AN IMPEDANCE ERROR MESSAGE APPEARED ON THE RECORDER. TRIED MULTIPLE CATHETERS AND DIFFERENT RECORDERS. ALL HAD THE SAME ERROR MESSAGE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : EGD. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE WAS HARD TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338343 DIVERSATEK HEALTHCARE ELECTRODE, PH, STOMACH FFT DIVERSATEK HEALTHCARE ZAI-BS-01 004802 00816734022252

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female