MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE DIVERSATEK HEALTHCARE; ZEPHR COMFORTEC PROBE

Model Number	ZAN-BG-44
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per maude adverse event report number mw5188839: it was reported that the zephr reflux probe malfunctioned and could not download the study.There were no patient complications reported, and it was confirmed by further follow up to the reporter that there was no patient harm.The study is downloaded after patient interaction, and the patient is no longer involved.Diversatek healthcare acknowledges receipt of the fda medwatch report referenced above.Upon receipt, the report was evaluated in accordance with our internal procedures and 21 cfr part 803.
Additional Manufacturer Narrative
The user facility report stated: probe malfunctioned and could not download study.It was reported that the zephr reflux probe malfunctioned and could not download the study.There were no patient complications reported, and it was confirmed by further follow up to the reporter that there was no patient harm.The study is downloaded after patient interaction, and the patient is no longer involved.The above facility did not reach out to diversatek healthcare prior to filing a medwatch report with the fda.However, if the reporter had reached out diversatek healthcare would not have reproted this incident to the fda becasue the malfunction reported by the user facility did not meet the criteria for mandatory reporting.The study is downloaded after patient interaction, and the patient is no longer involved.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.Based on a review of trending reports and the information available, the device does not pose a safety risk even if the download could not be performed.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: ZEPHR COMFORTEC PROBE
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 9150 commerce center circle; suite #500; highlands ranch WI 80129
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 9150 commerce center circle; suite #500 CO 80129
• Manufacturer Contact: laura boll ; 9150 commerce center circle; suite #500; highlands ranch, CO 80129 ; 4147554806
• MDR Report Key: 25739265
• Report Number: 2023374-2026-00003
• Device Sequence Number: 10412689
• Product Code: FFT
• UDI-Device Identifier: 00816734022283
• UDI-Public: 00816734022283
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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
• Device Model Number: ZAN-BG-44
• Device Catalogue Number: ZAN-BG-44
• Device Lot Number: 07/31/2026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 14 YR
• Patient Sex: Female