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

Model Number JB-70

Device Problems Bent (1059); Material Separation (1562)

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

Event Date 12/14/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017 it was reported to midmark by a service technician that a x-ray unit (jb-70, 76" reach 120v gray, serial (b)(4)) separated from the wall in which it was secured.There were no injuries reported by the complainant, however, a patient was struck in the head but did not seek medical attention.No other patient information has been disclosed.The unit mounting was visually inspected at the user facility and photographs were provided to midmark.The service technician reported that the top lag bolt was too close to the top of the structure and split the wood at that location causing the unit to separate from the wall.The service technician stated that when the unit separated from the wall, the chasis was bent.Jb-70 installation manual (00-02-01569_w), originally provided during the install of this unit gave clear, detailed instructions for unit installation.Per follow up questioning of the original reporter (a third party service technician) there is both evidence of wood split in the stud behind the dry wall of the examination room as well as admission by the customer that the arm of the jb-70 unit was used to hang lead aprons.There was no additional information on why the system had not undergone periodic operational and safety inspections by a qualified x-ray service organization at the time of this report.A replacement part was ordered and sent to the customer as the damaged part is now obsolete and have been replaced by a newer model of the unit.

• Brand Name: JB-70
• 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: 7183514
• MDR Text Key: 97878660
• Report Number: 1423380-2017-00001
• 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: distributor
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JB-70
• Device Catalogue Number: I7017G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2011
• 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