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

Model Number 0570-0352

Device Problems No Display/Image (1183); False Negative Result (1225); Low Test Results (2458)

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

Event Date 12/23/2014

Event Type  malfunction  

Event Description

On return to verathon, the aortascan was found to be reading inaccurately.All test measurements on a 3.7 cm aortic phantom were less than 3 cm.There was no pt impact.

Manufacturer Narrative

Additional device component: ami 9700 console ((b)(4)).Device eval summary: test scans were conducted on a 3.67 cm aortic phantom.The probe did not produce an image, and the measurement given was the default of less than 3 cm.The scan cable was evaluated on the cable eye test fixture, and an open circuit in the signal wire was found (the circf j1 pin 1 to circf j2 pin 3).This prevented the probe from sending an ultrasound image to the console to produce a measurement.After replacing the scan cable, the unit scanned correctly, measuring 3.7 cm on a 3.67 cm aortic test phantom.

• Brand Name: AORTASCAN AMI 9700
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON INCORPORATED; bothell WA
• Manufacturer Contact: adam gaines ; 20001 n creek pkwy.; bothell, WA 98011 ; 4256295606
• MDR Report Key: 4437674
• MDR Text Key: 5317096
• Report Number: 3022472-2015-00001
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• 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: 01/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• 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