PREVA PREVA, 76" REACH P7017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for PREVA PREVA, 76" REACH P7017 manufactured by Midmark Corporation.

Event Text Entries

[134916165] 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? " 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423380-2019-00001
• MDR Report Key: 8287250
• Date Received: 2019-01-29
• Date of Report: 2019-01-29
• Date of Event: 2018-12-28
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2019-01-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ADAM FORESMAN
• Manufacturer Street: 675 HEATHROW DRIVE
• Manufacturer City: LINCOLNSHIRE IL 60069
• Manufacturer Country: US
• Manufacturer Postal: 60069
• Manufacturer Phone: 2242204329
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PREVA
• Generic Name: PREVA DC
• Product Code: EAP
• Date Received: 2019-01-29
• Model Number: PREVA, 76" REACH
• Catalog Number: P7017
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIDMARK CORPORATION
• Manufacturer Address: 675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US 60069

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-29