MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE ZEPHR; SYSTEM, GASTROINTESTINAL MOTILITY

Model Number	Z07-2000-B-B
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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).

• Brand Name: ZEPHR
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY
• 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: 20146779
• Report Number: 2023374-2024-00001
• Device Sequence Number: 12861169
• Product Code: FFX
• UDI-Device Identifier: 00816734022177
• UDI-Public: 00816734022177
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012232
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Model Number: Z07-2000-B-B
• Device Catalogue Number: Z07-2000-B-B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown