MAUDE Adverse Event Report: MIDMARK CORPORATION JB-70

Model Number JB-70

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 it was reported to midmark by a dealer technician that an x-ray unit (jb-70, 76" reach 120 v gray, serial (b)(4)) separated from the wall in which it was secured.There were no injuries or contact with any person, as reported by the complainant.The unit mounting was visually inspected at the user facility by the technician and photographs were received by midmark technical service.The technician, after removal of the drywall at the location where the unit was mounted, discovered that the unit has been installed on a 2x4 wood stud.A metal junction box was also seen in the wall.The top lag bolt penetrated the 2x4 stud and caught in the metal plate at the back of the stud, causing the wood to split at the time of installation or over time due to repeat movements of the arm.The wall structure could no longer support the weight of the device; the installation guide was not used as instructed per the installation manual.Additional information obtained from the technician during the call indicates that the system did not undergo periodic operational and safety inspections by a qualified x-ray service organization.The unit was manufactured on 02/05/2014 and was shipped on 12/19/2014.As per follow-up performed on 05/11/2018 the technician re-installed the unit using a two stud mounting kit.

• Brand Name: JB-70
• Type of Device: JB-70
• 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: 7508874
• MDR Text Key: 108495452
• Report Number: 1423380-2018-00003
• Device Sequence Number: 1
• Product Code: EAP
• 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: distributor
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JB-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1