MAUDE Adverse Event Report: USCAN; ULTRASOUND IMAGING SYSTEM

Model Number	P005600
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ULTRASOUND IMAGING SYSTEM
• MDR Report Key: 11980131
• Report Number: 3013757696-2021-00001
• Device Sequence Number: 14283670
• Product Code: ITX
• UDI-Device Identifier: 09353278000113
• UDI-Public: (01)09353278000113(11)201202
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181574
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: P005600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other