MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, INTRAORAL

Model Number PREVA

Device Problems Detachment Of Device Component (1104); Structural Problem (2506)

Patient Problem No Information (3190)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 it was reported to midmark by a service technician than an x-ray unit (preva, 76" reach, serial number (b)(4)) separated from the wall in which it was secured.There were no injuries or contact with any persons as reported by the complainant.No other patient information has been disclosed.The unit mounting was visually inspected at the user facility by the technician and photographs were sent to midmark.The technician suspects there to be wood splitting ("stud split"), however, after removal of the drywall at the location where the unit was mounted, it was discovered that the top lag bolt did not fully penetrate the stud to the depth required to support the weight of the preva as is required per the midmark preva installation manual.Information obtained by midmark technical service during the call indicates the following: it is unknown if the structure has been modified in any way, the wall mounting is a single stud wall mount, the midmark installation guide was not used during install, the studs are not exposed, and the unit has a 76" reach in total.Conditions at the time of install are unknown.The unit was manufactured 03/11/2011 and shipped on (b)(6) 2011.Per the information obtained from the technician, the top lag bolt came loose from the wall (unbroken) while the bottom lag bolt remained secured to the wall.No other surfaces were damaged by the separation.Minor drywall damage to the wall was reported.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, INTRAORAL
• 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: 7426531
• MDR Text Key: 105679009
• Report Number: 1423380-2018-00002
• Device Sequence Number: 1
• Product Code: EAP
• 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: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PREVA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2011
• 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