MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number PREVA

Device Problems Component Falling (1105); Installation-Related Problem (2965)

Patient Problems Head Injury (1879); Loss of consciousness (2418)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Dealer tech performed inspection on site.

Event Description

On (b)(6) 2015 it was reported to midmark by a dealer representative that a x-ray unit (preva intraoral dental x-ray system, serial number (b)(4)) separated from its wall striking the patient present in the room at the time, in the head and rendering the person unconscious.The patient was taken to emergency room and was released the next day without additional issues reported.No other patient information has been disclosed.The unit mounting was visually inspected at the user facility and photographs were provided to midmark.Dealer representative reported that the upper lag bolt of the unit came out of the wood it was secused to and confirmed that the cause of this incident was installation error.Preva installation manual ((b)(4)) provided with the unit, gave clear, detailed instructions for unit installation on a dual stud wall.The unit has since been reinstalled by a dealer technician.Midmark also confirmed dealer's investigation and cause summary.

• Brand Name: PREVA
• 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 Key: 5316953
• MDR Text Key: 34079958
• Report Number: 1423380-2015-00024
• Device Sequence Number: 1
• Product Code: EHD
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: P7016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2013
• 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
• Patient Outcome(s): Hospitalization