MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO; VETPRO DC

Model Number VETPRO DC 2.0, 82" REACH W/TWO STUD MOUNT

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 it was reported to midmark by a dealer technician that an x-ray unit (vetpro dc 2.0,82" reach w/two stud mount; serial number (b)(4)) separated from the wall on which it was secured.There were no injuries to patients or staff members.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 wall structure on which the device was installed did not have the proper backing at the time of initial installation, as previously suggested by office staff.The unit was installed, using the original hardware provided with the x-ray system, through a wall cabinet and into drywall with the assumption that wood backing was present, using only 4 lag screws instead of 6.Proper wood backing was installed at the office after the machine separated and device was re-mounted on it, with a 1-inch distance between the surface of the wall cabinet to the front of the wood stud.It is unknown if the installation manual or installation template were used at the time of initial installation.No further information was provided.

• Brand Name: VETPRO
• Type of Device: VETPRO DC
• Manufacturer (Section D): MIDMARK CORPORATION; 1001 asbury dr.; buffalo grove IL 60089
• MDR Report Key: 11537043
• MDR Text Key: 280509170
• Report Number: 1423380-2021-00001
• Device Sequence Number: 1
• Product Code: EAP
• Combination Product (y/n): N
• PMA/PMN Number: K043092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: VETPRO DC 2.0, 82" REACH W/TWO STUD MOUNT
• Device Catalogue Number: DCV8-G2A/H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1