MAUDE Adverse Event Report: MIDMARK CORP PREVA

Model Number PREVA

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 it was reported to midmark by a dealer tech that an x-ray unit (preva intraoral dental x-ray system, serial no (b)(4)) separated from its wall mounting at a user facility in (b)(4).No injuries were reported.The dealer tech visually inspected the wall and provided photographs to midmark.Root cause could not be confirmed; however, the info collected may suggest that the unit separated from the wall due to improper installation.The photographs reviewed do not indicate that the midmark installation guide tool was used.This tool is used to locate the ctr of the stud to help ensure stable mounting.The electrical box was also placed behind the chassis, which is not a configuration recommended by the installation instructions.

• Brand Name: PREVA
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow dr; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow dr; lincolnshire, IL 60069 ; 8474159739
• MDR Report Key: 4742626
• MDR Text Key: 5827415
• Report Number: 1423380-2015-00014
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: DN67397
• Device Lot Number: P7016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2009
• 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