MAUDE Adverse Event Report: MIDMARK CORPORATION JB-70 INTRAORAL DENTAL X-RAY SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number JB-70

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

Inspection of the unit by an on-site service technician revealed that it was mounted on the wall with a single stud mount, with a lag screw into two sandwiched 3/4" press boards, the press board was mounted onto one 2x4 stud.The dry wall and press board (particle board) appeared damaged and there was no midmark installation guide tool used for this installation.The unit had been moved from its original location and installed in june or july 2016 by a third party company (exact date is unknown).The installer did not comply with the installation requirements provided in the jb-70 installation and service manual.The jb-70 installation and service manual details a proper procedure for installation of the unit which includes examples of using improper surfaces such as a particle board, and the need for an installation guide tool.Root cause of the mounting failure is determined to be improper installation by a third party company technician not certified by midmark.Should additional relevant information become available, a supplemental report will be submitted.Inspected on-site.

Event Description

It was reported that an x-ray unit had partially separated from the wall injuring a patient.The patient was struck by the tubehead and sustained injury to his nose and lip; patient was taken to urgent care.The reporter stated that the articulating arm also contacted the patient's chest however no injury resulted in the chest area.At the time of the incident the patient and dental assistant were present.The patient's recovery status and outcome of the event were not reported.No additional information is available.

• Brand Name: JB-70 INTRAORAL DENTAL X-RAY SYSTEM
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer (Section G): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 2242204329
• MDR Report Key: 6104384
• MDR Text Key: 59967879
• Report Number: 1423380-2016-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K020070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Service Personnel
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: JB-70
• Device Catalogue Number: I7017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2005
• 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): Required Intervention