DIVERSATEK HEALTHCARE
Received Jul 7, 2026 · Event occurred May 14, 2026
Report 2023374-2026-00003 · MDR key 25739265
Device
Generic name
Zephr Comfortec Probe
Manufacturer
Diversatek HealthcareModel number
ZAN-BG-44Catalog number
ZAN-BG-44
Lot number
07/31/2026
Product problems
- No Apparent Adverse Event
Patient
14 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.