MAUDE Adverse Event Report: COLTENE/WHALEDENT INC. COLTENE/WHALEDENT INC.; UC 95 ULTRASONIC CLEANER

Model Number BIOSONIC ULTRASONIC CLEANER

Device Problem Fire (1245)

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

Event Date 02/25/2016

Event Type  malfunction  

Event Description

Office personnel walked into the room and observed the unit already emitting a blue flame.No smoke was observed (but this may have occurred prior to the blue flame).Incident occurred around mid day during a standard cleaning cycle, perhaps the second cycle of the day.

• Brand Name: COLTENE/WHALEDENT INC.
• Type of Device: UC 95 ULTRASONIC CLEANER
• Manufacturer (Section D): COLTENE/WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE/WHALEDENT INC; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: bruce kucharski ; 235 ascot parkway; cuyahoga falls, OH 44223 ; 3309168932
• MDR Report Key: 5529138
• MDR Text Key: 41637123
• Report Number: 2416455-2016-03002
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 02/26/2016,03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BIOSONIC ULTRASONIC CLEANER
• Device Catalogue Number: UC95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2016
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 02/26/2016
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1