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

Model Number 0570-0188

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/15/2013

Event Type  malfunction  

Event Description

The customer complained of aorta scan inaccuracy when an abdominal aortic aneurysm was not identified.A pt was scanned with a verathon representative's demonstration device in (b)(6) 2013, and the results did not show any aneurysm.On (b)(6) 2013, the pt underwent a ct for an unrelated intestinal problem, and a 5.0 cm abdominal aortic aneurysm was found.The reported malfunction had no adverse effect on the pt.

Manufacturer Narrative

The report of inaccurate scans could not be confirmed; the device was found to be working properly.Over ten scans were conducted, both in bladder and aortic mode, and all were within the published range.The probe was then disassembled and inspected; no damage was found.The scan cable was also tested for any shorts, and none were found.The pcba was also visually inspected for damaged components, and none were found.Console system component: (b)(4).

• Brand Name: BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
• Type of Device: AORTIC ULTRASOUND SCANNER
• Manufacturer (Section D): VERATHON MEDICAL; bothell WA
• Manufacturer Contact: adam gaines, sr. complaint spe ; 20001 north creek parkway; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3787368
• MDR Text Key: 4432442
• Report Number: 3022472-2014-00003
• Device Sequence Number: 1
• Product Code: IYO
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• 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: 01/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2004
• 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: 70 YR