MAUDE Adverse Event Report: FUJIFILM TECHNO PRODUCTS CO., LTD.. TOHOKU FUJINON; ULTRASOUND KEYBOARD

Model Number CP-1

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

The root cause of the malfunction has not yet been identified.Investigation is in progress and troubleshooting attempts were made on site.The subject device will be tested once received from the customer.

Event Description

On (b)(6) 2017, during an ultrasound therapeutic procedure, the touch screen part of the cp-1 keyboard froze, preventing the physician from annotating.The system was rebooted, the keyboard resumed normal function and the procedure was completed.No patient injury was reported.

Manufacturer Narrative

On (b)(6) 2017, (b)(4) communicated a remedial action for the issue of freezing touch panel on the keyboard.Electrostatic charge on the pad can cause it to be unresponsive.As a result, a software change to the keyboard itself will reset the touchpad instantaneously upon touching the keyboard, rendering it operable by the user with no delay.Affected customers will have their keyboards updated with the software onsite as part of a field action.The issue does not cause any risk to patient health.

• Brand Name: FUJINON
• Type of Device: ULTRASOUND KEYBOARD
• Manufacturer (Section D): FUJIFILM TECHNO PRODUCTS CO., LTD.. TOHOKU; 2-1-3 kitayuguchi; hanamaki-shi iwate, 025-0 301; JA 025-0301
• Manufacturer (Section G): FUJIFILM TECHNO PRODUCTS CO., LTD.. TOHOKU; 2-1-3 kitayuguchi; hanamaki-shi iwate, 025-0 301; JA 025-0301
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 6648899
• MDR Text Key: 78062192
• Report Number: 2431293-2017-00061
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CP-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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