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

Model Number 0570-0188

Device Problem False Negative Result (1225)

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

Event Date 06/06/2014

Event Type  malfunction  

Event Description

The customer stated that the bvi 9600 was inaccurate in aortascan mode, and did not detect a known abdominal aortic aneurysm.No adverse effect to the pt was reported.According to the user's manual the pt must fast at least 12 hours prior to the procedure.The pt did not fast the specified 12 hours prior to the procedure, thus the customer indicated signs of bowel gas impacted the reading.The device was returned to verathon for eval.

Manufacturer Narrative

Device eval summary: the device eval did not confirm the report of inaccurate readings.No problem was found with accuracy.All aorta phantom scans were within 0.1 cm on a 3.7 phantom measurement, which is within published range.Ultrasound images all look correct.Additional system component: 0570-0212/b6002524.A letter dated on 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 pts should be referred for a diagnostic standard (confirmatory) test, regardless of test results.Concomitant product: not applicable, no pt 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: carmen wassell ; 20001 north creek parkway; bothell, WA 98011 ; 4256295674
• MDR Report Key: 3998241
• MDR Text Key: 4822993
• Report Number: 3022472-2014-00021
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/06/2014

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
• Device Operator: Health Professional
• Device Model Number: 0570-0188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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