MAUDE Adverse Event Report: ECHONOUS, INC. USCAN; ULTRASOUND IMAGING SYSTEM

Model Number P005600

Device Problem Output Problem (3005)

Patient Problem Urinary Retention (2119)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to echonous.Testing was performed on phantom (bladder reference) and an employee bladder to confirm it is functioning as intended.The probe was tested by two employees on a gold standard phantom with a known volume and found to be in specification.The probe was also used to scan an employee's bladder and met measurement specification of the voided volume.Results from internal testing show there is no issue with the probe function (ultrasound image acquisition, bladder volume estimation).The likelihood of customer experiencing inaccurate scans may be attributed to training or improper scanning of the patient.Based on the results of internal testing, it can be concluded that there is no issue with the probe, and it is functioning as per the specification.

Event Description

Patient had not produced any urine from his foley catheter for over 8 hours.Bladder scanner had a result of 18 then about 25 cc of urine present in his bladder.This patient had had a bladder repair in addition of bowel surgery and the results of the bladder scanner made the on-call telehospitalist call the in-house hospitalist for a referral.A stat ct of his abdomen and an x-ray were ordered to rule out kidney failure and a iv fluid bolus was ordered.It must be noted that this patient also had an ngt for an ileus.When the patient returned from the imaging exams, we received an order to flush the catheter.Almost immediately about 400cc of urine flowed into the catheter bag.

• Brand Name: USCAN
• Type of Device: ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): ECHONOUS, INC.; 8310 154th avenue ne; building b, suite 200; redmond WA 98052 6180
• MDR Report Key: 11980131
• MDR Text Key: 263490035
• Report Number: 3013757696-2021-00001
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 09353278000113
• UDI-Public: (01)09353278000113(11)201202
• Combination Product (y/n): N
• PMA/PMN Number: K181574
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Model Number: P005600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other