MAUDE Adverse Event Report: VERATHON INC. BVI 9400; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number BVI 9400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Dysuria (2684)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Patient had urology procedure and was unable to void in pacu.Bladder scan was done and the reading was 480 ml.Patient was isc'd (internal straight cath) for 800 ml urine in bladder.This is a significant difference and there is potential for patient harm when the device is so inaccurate.Feedback from clinical user, concerns about ".Basing clinical decisions on the values given by the scanner (i.E., whether or not to catheterize a patient based on the volume of urine in the bladder, as indicated by the scanner)." manufacturer response for bladder scanner, bvi 9400 bladder scanner (per site reporter).
=
calibration was checked and found within parameters.

• Brand Name: BVI 9400
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON INC.; 20001 north creek parkway; bothell WA 98011
• MDR Report Key: 4146509
• MDR Text Key: 20781904
• Report Number: 4146509
• Device Sequence Number: 1
• Product Code: IYO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: BVI 9400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2014
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 101