MAUDE Adverse Event Report: MIDMARK CORP JB-70; UNIT, X-RAY, EXTRAORAL WITH TIMER

Model Number JB-70

Device Problems Crack (1135); Installation-Related Problem (2965)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

It was reported to midmark that on (b)(6) 2015, an x-ray unit (jb-70 intraoral dental x-ray system, serial # (b)(4)) separated from its wall mount in a user facility.No injuries were reported.Investigation of the mounting site by a dealer technician determined that the top lag screw was not centered in the stud, and the stud had cracked.Also, photographs show that there is continuous wallpaper at the site of mounting, which indicates that at the time of installation, the wall had not been opened to visualize the stud and that the "installation guide" tool had not been used.Because the installation instructions require that the lag screws are centered in the stud and the stud be loaded visually through opening the wall using the installation guide, root cause of the mounting failure is determined to be improper installation.

• Brand Name: JB-70
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow dr; lincolnshire IL 60069
• Manufacturer Contact: nataliya khutoma ; 675 heathrow dr; llincolnshire, IL 60069 ; 8474159760
• MDR Report Key: 4551489
• MDR Text Key: 5527716
• Report Number: 1423380-2015-00010
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JB-70
• Device Catalogue Number: JT27098
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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