MAUDE Adverse Event Report: VERATHON MEDICAL AORTASCAN AMI 9700; AORTIC ULTRASOUND SCANNER

Model Number 0570-0352

Device Problems False Negative Result (1225); Low Test Results (2458)

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

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The customer reported that the aortascan was giving a negative result.An ultrasound testing was performed and found that the patient had a 4.4 cm aortic aneurysm.There was no adverse event to the patient.

Manufacturer Narrative

Additional device component: ami 9700 console ((b)(4)).Device evaluation summary: the reported problem could not be duplicated with test scans on an aorta phantom.All scans were within the diameter accuracy range listed in the operations and maintenance manual.The device measured 3.7 cm on a 3.7 cm phantom.

• Brand Name: AORTASCAN AMI 9700
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON MEDICAL; bothell WA
• Manufacturer Contact: carmen wassell ; 20001 n creek pkwy; bothell, WA 98011 ; 4256295674
• MDR Report Key: 4574729
• MDR Text Key: 5559545
• Report Number: 3022472-2015-00009
• 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
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0352
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Unknown
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 74 YR
• Patient Weight: 107