MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO

Model Number 30-A1066

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

An inventory manager of an animal hospital reported to midmark that one of the legs of a vetpro mobile x-ray unit, serial number (b)(4), broke off from the mobile base at the weld.The leg broke off when it was moved to its storage location after use.Midmark confirmed that there was no injury.The same mobile base structure is also used on the preva x-ray units supplied to dental offices.

• Brand Name: VETPRO
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow dr.; lincolnshire IL 60069
• Manufacturer Contact: peng lin ; 675 heathrow dr.; lincolnshire, IL 60065 ; 8474159787
• MDR Report Key: 4097883
• MDR Text Key: 19765061
• Report Number: 1423380-2014-00006
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30-A1066
• Device Catalogue Number: DCVM-G0A/S2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1