MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO DC

Model Number VETPRO DC, 76" REACH SYSTEM W/TWO STUD MOUNT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/25/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 it was reported to midmark by a dealer technician that an x-ray unit (vetpro dc, 76" reach; serial number (b)(4)) separated from the wall in which it was secured.There were no injuries to people or animals and no equipment was damaged.This machine was reinstalled by a non-midmark certified service company (proactive tech solutions, inc.) as the doctor's office recently moved.Dr.(b)(6) and assistant (b)(6) were present at the time the x-ray machine was reinstalled.The unit mounting was visually inspected at the user facility by the technician but no photographs were submitted to midmark.The technician, after inspection of the mounting apparatus and after the customer's confirmation concluded that the machine detached from ¾ plywood backing behind the wall used by the service company.This is not an approved installation method but the customer refused to follow midmark's recommendation.Midmark's technical support group recommended service provider to the customer for further evaluation and repair but they refused the recommendation since they wanted to contact their preferred installer.Midmark is closing this investigation because customer is refusing any recommendation provided by midmark's technical support group and field technician and because of the lack of evidence provided by them.

• Brand Name: VETPRO DC
• Type of Device: VETPRO DC
• Manufacturer (Section D): MIDMARK CORPORATION; 1001 asbury dr; buffalo grove IL 60089
• Manufacturer Contact: adam foresman ; 1001 asbury dr; buffalo grove, IL 60089 ; 2242204329
• MDR Report Key: 8743890
• MDR Text Key: 149948304
• Report Number: 1423380-2019-00003
• 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: Repair
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: VETPRO DC, 76" REACH SYSTEM W/TWO STUD MOUNT
• Device Catalogue Number: P7017V-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2019
• 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