BLADDERSCAN BVI 3000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-01 for BLADDERSCAN BVI 3000 * manufactured by Verathon Inc..

Event Text Entries

[15559759] The pt has a diagnosis of bilateral hydronephrosis. The dr ordered a non-invasive bladder scan to determine if there was any residual urine in the bladder. The nurse utilized the bladder scanner which did not detect any urine in the bladder. The probe had a crack in it. The issue is that when the bladder scanner did its "self test" it did not detect a defective probe. A second scanner was obtained and detected the urine in the bladder. There was a delay in determining the volume of urinary retention in the pt who had hydronephrosis and a urinary tract infection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1731685
• MDR Report Key: 1731685
• Date Received: 2010-06-01
• Date of Report: 2010-06-01
• Date of Event: 2010-05-26
• Report Date: 2010-06-01
• Date Reported to FDA: 2010-06-01
• Date Added to Maude: 2010-06-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BLADDERSCAN BVI 3000
• Generic Name: CYSTOMETER, BLADDER SCAN
• Product Code: EXQ
• Date Received: 2010-06-01
• Model Number: BVI 3000
• Catalog Number: *
• Lot Number: 400370024
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 5 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VERATHON INC.
• Manufacturer Address: 20001 NORTH CREEK PARKWAY BOTHELL WA 98011 US 98011

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-06-01