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U.S. Department of Health and Human Services

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

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MIDMARK CORPORATION JB-70 UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
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 A replacement part was ordered and sent to the customer as the damaged part is now obsolete and have been replaced by a newer model of the unit.
 
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Brand NameJB-70
Type of DeviceUNIT, 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 Key7183514
MDR Text Key97878660
Report Number1423380-2017-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020070
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberJB-70
Device Catalogue NumberI7017G
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/04/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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