MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER,

Model Number PREVA

Device Problems Fire (1245); Sparking (2595); Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a dentist reported to midmark that the tube head of a preva intraoral x-ray unit (serial no.(b)(4)) emitted a flame while the unit was being positioned.A dental hygienist and patient were present at the time.No injuries were reported.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER,
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow dr.; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 2242204329
• MDR Report Key: 5096455
• MDR Text Key: 26840809
• Report Number: 1423380-2015-00021
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PREVA
• Device Catalogue Number: P7017-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• 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