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

Model Number PREVA

Device Problems Material Separation (1562); Installation-Related Problem (2965)

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

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

Dealer tech performed inspection on-site.

Event Description

On (b)(6) 2015, it was reported to midmark by a dealer technician 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)(6).No injuries were reported.The mounting was visually inspected at the user facility, and photographs were provided to midmark.It was observed that the device was bolted to the wall using plywood as a backing material.The product installation instructions state that plywood is not an acceptable mounting material (refer to "preva dental x-ray system installation and service manual," (b)(4)), and the cause of this incident is thus determined to be installation error.The unit has since been reinstalled using the two-stud procedure per manufacturer instructions.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 2242204329
• MDR Report Key: 5208063
• MDR Text Key: 30982238
• Report Number: 1423380-2015-00023
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: P7017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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