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

Model Number JB-70

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

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

Event Date 10/27/2008

Event Type  malfunction  

Event Description

It was reported to midmark that an x-ray unit (jb-70 intraoral dental x-ray system, serial no.(b)(4)) separated from its wall mount in a user facility.No injuries were reported.Root cause was determined to be installation error due to use of improper backing material.The mounting bolts pulled through the backing, causing the unit to separate from the wall.This mdr is being submitted as part of retrospective complaint review conducted at midmark corporation ((b)(6)).Midmark (formerly progeny) began filing mdrs for x-ray units separating from their wall mounts in (b)(6) 2009 (refer to mdr 1423380-2009-00006).All subsequent incidents involving units fully separating from the wall mount have been submitted to cdrh as mdrs.However, as part of retrospective complaint review, midmark has identified this unreported incident that occurred prior to (b)(6) 2009 and has decided to report this incident for consistency.

• Brand Name: JB-70
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER, PRODUCT CODE: EHD
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: nataliya khutorna ; 675 heathrow drive; lincolnshire, IL 60069 ; 8474159760
• MDR Report Key: 4546574
• MDR Text Key: 5511882
• Report Number: 1423380-2015-00007
• 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: 10/27/2008

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JB-70
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2008
• Initial Date FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2007
• 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