MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE; AORTIC ULTRASOUND SCANNER

Model Number 0570-0351

Device Problems False Negative Result (1225); Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

The customer stated that the aortascan did not find a previously identified abdominal aortic aneurysm, and that the device was giving varied positive and negative readings on the same patient.This may have been due to improper use, as the customer was not aware of the directions in the user's manual pertaining to patient preparation and scanning technique.There was no adverse impact to the patient.

Manufacturer Narrative

Device evaluation summary: testing of the aorta scan did not identify any problem with the device.Sixty total scans were conducted on three different tissue equivalent aorta phantoms, and all scans were within the published range of accuracy.Additionally, the scan cable passed a cable test up to 165 cycles on a test device.To address any issues with misuse, a verathon representative conducted an in depth device training with the entire staff of the facility.Additionally, a letter dated 05/29/2014, has been sent to all customers, informing them of enhancements to the warnings in the user's manual which provide additional guidance and awareness on the proper use of the aortascan.The operations and maintenance manual states that the aortascan is not a diagnostic device and is only intended as an initial screening tool.If clinically indicated, appropriate patients should be referred for a diagnostic standard (confirmatory) test, regardless of test results.Additional device component: 0570-0212/b6002303.No patient adverse event.

• Brand Name: BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON MEDICAL; bothell WA
• Manufacturer Contact: adam gaines ; 20001 north creek parkway; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3987636
• MDR Text Key: 4755115
• Report Number: 3022472-2014-00019
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0351
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1