Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
Model Number P7017
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 05/15/2014
Event Type  malfunction  
Event Description
A dental assistant of a dental office reported to a dealer field technician who then reported to midmark that a preva x-ray unit, serial number (b)(4), would generate an exposure on its own while the arm was moved from position to position.
 
Manufacturer Narrative
The dealer field technician of the distributor performed an on-site investigation with remote support from (b)(6) engineering.Through a series of tests and investigations (b)(4) 2014, the dealer field technician discovered that the failure was caused by the cable that connected the control unit and the remote switch.The cable is located behind the wall.A screw went through the cable and shorted the two low voltage wires resulting in the uncommanded exposure.The installation error caused the uncommanded exposure.The uncommanded exposure was caused by installation error.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
peng lin
675 heathrow dr
lincolnshire, IL 60065
8474159787
MDR Report Key3987675
MDR Text Key4636958
Report Number1423380-2014-00004
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 Other
Type of Report Initial
Report Date 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP7017
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-