MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE ZVU HRIM PROBE; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	HRIM-201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description from mw5162137 voluntary user report: prior to patient: probe was tested under the calibration process and appeared to be in working order.All sensors were green which indicated all sensors were working properly.Probe inserted into nare without difficulty.Data reflected on screen showed that probe needed inserted more and that there was possible coiling.Pulled probe out approximately 6 cm (in order to fix possible coiling) and then advanced probe.Patient tolerated well.Still did not see accurate data on the monitor (needed advanced more to see the outflow portion of the swallow).Sat patient up to attempt better placement again.Pulled probe out approximately halfway and patient pointed to mouth (probe was now coiled in her mouth after some mild coughing/gagging).It was decided to completely remove the probe in order to try a second attempt.Once probe was removed it was immediately noticed that it was broken.Patient tolerated well.No visible bleeding from mouth/nares.Small amount of blood was noted on probe.
Additional Manufacturer Narrative
The user facility did contact the manufacturer on 29 october 2024 prior to filing a medwatch report with fda (mw5162137).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 from fda on 29 november 2024.The user facility report reported: prior to patient: probe was tested under the calibration process and appeared to be in working order.All sensors were green which indicated all sensors were working properly.Probe inserted into nare without difficulty.Data reflected on screen showed that probe needed inserted more and that there was possible coiling.Pulled probe out approximately 6 cm (in order to fix possible coiling) and then advanced probe.Patient tolerated well.Still did not see accurate data on the monitor (needed advanced more to see the outflow portion of the swallow).Sat patient up to attempt better placement again.Pulled probe out approximately halfway and patient pointed to mouth (probe was now coiled in her mouth after some mild coughing/gagging).It was decided to completely remove the probe in order to try a second attempt.Once probe was removed it was immediately noticed that it was broken.Patient tolerated well.No visible bleeding from mouth/nares.Small amount of blood was noted on probe.The manufacturer investigated this complaint and determined it did not meet the threshold for reportability because an adverse event had not occurred and the product malfunction could not cause or contribute to a serious injury.The product design has redundant systems to secure the tip in the event of breakage to prevent separation.While this breakage may cause minor irritation of the gi tract, it will not cause or contribute to a serious patient injury.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: ZVU HRIM PROBE
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 9150 commerce center circle; suite 500; highlands ranch CO 80129
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 9150 commerce center circle; suite 500; highlands ranch CO 80129
• Manufacturer Contact: laura boll ; 9150 commerce center circle; suite 500; highlands ranch, CO 80129 ; 4142657620
• MDR Report Key: 21084847
• Report Number: 2023374-2024-00003
• Device Sequence Number: 17867300
• Product Code: FFX
• UDI-Device Identifier: 00816734022689
• UDI-Public: 00816734022689
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190208
• 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): 12/23/2004

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: HRIM-201
• Device Catalogue Number: HRIM-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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: Female