MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE DIVERSATEK HEALTHCARE; ELECTRODE, PH, STOMACH

Model Number	ZAI-BS-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: DIVERSATEK HEALTHCARE
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 9150 commerce center circle; #500; highlands ranch CO 80129
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 9150 commerce center circle; #500; highlands ranch CO 80129
• Manufacturer Contact: laura boll ; 9150 commerce center circle; #500; highlands ranch, CO 80129 ; 4147554806
• MDR Report Key: 20518166
• Report Number: 2023374-2024-00002
• Device Sequence Number: 7765218
• Product Code: FFT
• UDI-Device Identifier: 00816734022252
• UDI-Public: 00816734022252
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: ZAI-BS-01
• Device Catalogue Number: ZAI-BS-01
• Device Lot Number: 004802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female