MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE SANDHILL SCIENTIFIC INSIGHT ULTIMA; GASTROINTETINAL MOTILITY MONITORING SYSTEM

Model Number	H12R-2000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current medwatch report mw5087436 does not contain enough information to do a complete investigation.Mw5087436 states: "unable to initiate the use of the sandhill scientific insight ultima manometry system after numerous attempts".A review of all complaint records showed this customer did not report this event to the (b)(4) healthcare.Customer was contacted for additional information but none was provided.The first step for use of the ultima is to turn it on and connect it to a manometry probe outside the patient.Calibration of the probe is then performed.If the user could not initiate use of the ultima 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 ultima were to fail during a manometry 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 ultima has been started, so the inability to initiate use would never involve a patient.(b)(4) 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
Per customer report mw5087436 "unable to initiate the use of the sandhill scientific insight ultima, manometry system after numerous attempts.".

• Brand Name: SANDHILL SCIENTIFIC INSIGHT ULTIMA
• Common Device Name: GASTROINTETINAL MOTILITY MONITORING SYSTEM
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 9150 commerce center circle; suite 500; highlands ranch CO 80129
• MDR Report Key: 9234865
• Report Number: 2183446-2019-00002
• Device Sequence Number: 398290
• Product Code: FFX
• UDI-Device Identifier: 00816734021941
• UDI-Public: 00816734021941
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: H12R-2000
• Device Catalogue Number: H12R-2000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other