MAUDE Adverse Event Report: SANDHILL SCIENTIFIC UNISENSOR UNITIP HIGH RESOLUTION CATHETER; SYSTEM, GASTROINTESTINAL MOTILITY

Model Number US-05-2306

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The user facility report was incorrectly sent to (b)(4), which is only the distributor of the device in this report.The legal manufacturer of the device is unisensor usa.(b)(4) forwarded the report to unisensor upon receipt.(b)(4) also sent the affected device to unisensor for evaluation.Unisensor evaluated the device under their report reference number (b)(4) and found no basis for the complaint as described.Based on excerpts from the (b)(4) call logs, the malfunction was likely caused by equipment mishandling by the user.(b)(4) reviewed the study and found proper calibration and set up at 7:52am.However, it appears as if subsequent setup was not saved.Calibration values wouldn't save if the user inadvertently pressed 'don't save calibration values'.The screen to choose existing patient and the water verification would have been fine but the pressure cal values weren't applied to this study so the system would default to the last cal values at 7:52 am.Since unisensor is the legal manufacturer of this device, unisensor is providing the 3500a response to this user report.

Event Description

See user report.

• Brand Name: UNISENSOR UNITIP HIGH RESOLUTION CATHETER
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY
• Manufacturer (Section D): SANDHILL SCIENTIFIC
• Manufacturer Contact: laura boll ; 9150 commerce center circle; #500; highlands ranch, CO 80129 ; 3034707020
• MDR Report Key: 5594589
• MDR Text Key: 44455290
• Report Number: 2023374-2016-00001
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• PMA/PMN Number: K062222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US-05-2306
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1