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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER,
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MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER, Back to Search Results
Model Number PREVA
Device Problems Break (1069); Fracture (1260); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, it was reported to midmark that an x-ray unit (preva intraoral dental x-ray system, serial number (b)(4)) partially separated from its wall mounting at a user facility in (b)(6).One of the two fasteners (long socket cap screws) that bolt the control unit to the wall plate fractured, causing the control unit to rotate sideways and the tube head to make contact with the ground.No injuries were reported.The unit has been remounted, and the broken screw was returned to midmark for evaluation.
 
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Brand Name
PREVA
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER,
Manufacturer (Section D)
MIDMARK CORPORATION
675 heathrow dr.
lincolnshire IL 60069
Manufacturer Contact
adam foresman
675 heathrow drive
lincolnshire, IL 60069
8474159739
MDR Report Key4966076
MDR Text Key23423405
Report Number1423380-2015-00019
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 distributor
Reporter Occupation Service and Testing Personnel
Remedial Action Other
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPREVA
Device Catalogue NumberP7017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2014
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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