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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO DC; UNIT, X-RAY, EXTRAORAL WITH TIMER
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MIDMARK CORPORATION VETPRO DC; UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
Model Number VETPRO DC
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2015
Event Type  malfunction  
Manufacturer Narrative
Dealer tech performed inspection on-site.
 
Event Description
On (b)(6) 2015, it was reported to midmark by a user facility practice manager that an x-ray unit (vetpro x-ray system, (b)(4) separated from its wall mounting at a veterinary hospital in (b)(6).No injuries were reported.The mounting was visually inspected at the user facility, and photographs were provided to midmark.It was determined that the unit was not properly installed, as the machine was bolted into a plaster wall without the use of wooden studs, which is not an acceptable mounting per the installation instructions.
 
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Brand Name
VETPRO DC
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER
Manufacturer (Section D)
MIDMARK CORPORATION
675 heathrow drive
lincolnshire IL 60069
Manufacturer Contact
adam foresman
675 heathrow drive
lincolnshire, IL 60069
2242204329
MDR Report Key5208061
MDR Text Key30985133
Report Number1423380-2015-00022
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 10/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberVETPRO DC
Device Catalogue NumberP7017V-P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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