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U.S. Department of Health and Human Services

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

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ECHONOUS, INC. USCAN ULTRASOUND IMAGING SYSTEM Back to Search Results
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.
 
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Brand NameUSCAN
Type of DeviceULTRASOUND IMAGING SYSTEM
Manufacturer (Section D)
ECHONOUS, INC.
8310 154th avenue ne
building b, suite 200
redmond WA 98052 6180
MDR Report Key11980131
MDR Text Key263490035
Report Number3013757696-2021-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K181574
Number of Events Reported1
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
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP005600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/10/2021 Patient Sequence Number: 1
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