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

Model Number 0570-0309

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

The customer reported that the aorta scan did not identify an abdominal aortic aneurysm (aaa), but then at a later date a aaa was found when the patient underwent other testing.There have been no adverse consequences to the patient.Further details have been requested from the facility.

Manufacturer Narrative

A verathon representative is scheduling a visit with the customer to obtain additional details on the complaint and assess the reported problem with the device.Additional system component: 0570-0303/a7001236.A letter dated may 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.

• Brand Name: AORTASCAN AMI 9700
• 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: 4019778
• MDR Text Key: 4692788
• Report Number: 3022472-2014-00022
• 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: Not Applicable
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/12/2014

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: 0570-0309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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