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

Model Number 0570-0188

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

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

The customer stated that the aortascan was reading <3cm on all patient scans, suggesting that the unit may be giving inaccurate measurements.Additionally, the device is not displaying a scan image.No patient impact was reported.

Manufacturer Narrative

(b)(4).A return authorization was arranged for the customer to send the aortascan back for evaluation.To date the device has not been returned.A letter dated may 29, 2014, has been sent to all customers, informing them of enhancements to the warning's in the user manual which provide additional guidance and awareness on the proper use of the aortascan.The operations and maintenance manual states that the aortascan is not a diagnostic device and is only intended as an initial screening tool.If clinically indicated, appropriate patients should be referred for a diagnostic standard (confirmatory) test, regardless of test results.

• 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 ; 20001 north creek pkwy; bothell, WA 98011 ; 4256295606
• MDR Report Key: 4122164
• MDR Text Key: 4937464
• Report Number: 3022472-2014-00033
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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