MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO; VETPRO DC

Model Number VETPRO DC 2.0

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 it was reported to midmark by a dealer technician that an x-ray unit (vetpro dc 2.0, 76" reach, w/two stud mount; serial number (b)(4)) separated from the wall in which it was secured.There were no injuries or contact with any person.The unit detached from the wall when the facility was closed and discovered in the morning by facility staff, as reported by the complainant.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 bolts were not properly installed by the installation technician at the time of unit install.The lag bolts, provided by midmark, were installed into the wall and did not correctly connect with the stud causing the machine to not be securely attached to the wall.The original hardware provided with the x-ray system was observed to be present but the lag screws were mounted off-center on the stud or completely missed the stud.It is unknown if the installation manual was 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; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 2242204329
• MDR Report Key: 8018741
• MDR Text Key: 126553095
• Report Number: 1423380-2018-00004
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: VETPRO DC 2.0
• Device Catalogue Number: DCV7-G2A/H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• 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