MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; PREVA DC

Model Number PREVA, 76" REACH

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 12/28/2018

Event Type  malfunction  

Event Description

On 12/31/2018 it was reported to midmark by a dealer technician that an x-ray unit (preva, 76" reach; serial number (b)(4)) separated from the wall in which it was secured.There were no injuries although the tubehead contacted the patient, (b)(6), who refused treatment.(b)(6), a dental hygienist was present at the time of the incident ((b)(6)).The unit mounting was visually inspected at the user facility by the technician and photographs were received by midmark technical services.The technician, after inspection of the mounting apparatus concluded that the 3" top lag bolt provided by midmark pulled out of the single stud, causing damage to the wall and for the chassis to bend.The mounted unit was centered on a 2x4 stud (sheet rock was cut to visualize it along with the ½" distance between this and the wall) with a lag bolt on top and bottom along with a stabilizing screw on the bottom.There is no evidence of wood split but the top hole was dislodged approximately 2" lower to get into clean wood.It is unknown if the pre-installation requirements were met; if the installation template was used; or if the facility uses the device to hang lead aprons.The installation manual was not used at the time of initial installation.No further information was provided.

• Brand Name: PREVA
• Type of Device: PREVA DC
• 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: 8287250
• MDR Text Key: 134916165
• Report Number: 1423380-2019-00001
• 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: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA, 76" REACH
• Device Catalogue Number: P7017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1