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

Model Number 0570-0309

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 01/06/2015

Event Type  malfunction  

Event Description

The customer reported that the aortascan was giving inaccurate readings.The unit measured less than 3 cm, when the pt was known to have a 5 cm aortic aneurysm.There was no adverse event to the pt.

Manufacturer Narrative

Additional device component: ami 9700 console ((b)(4)).A return authorization has been arranged for the customer to send the unit back to verathon for eval.

• Brand Name: AORTASCAN AMI 9700
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON MEDICAL; bothell WA
• Manufacturer Contact: adam gaines ; 20001 n creek pkwy; bothell, WA 98011 ; 4256295606
• MDR Report Key: 4437692
• MDR Text Key: 5312943
• Report Number: 3022472-2015-00003
• 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: 01/06/2015

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: 0570-0309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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