JB-70 I7017G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for JB-70 I7017G manufactured by Midmark Corporation.

Event Text Entries

[97878660] 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 A replacement part was ordered and sent to the customer as the damaged part is now obsolete and have been replaced by a newer model of the unit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423380-2017-00001
MDR Report Key7183514
Date Received2018-01-11
Date of Report2018-01-11
Date of Event2017-12-14
Date Mfgr Received2017-12-14
Device Manufacturer Date2011-11-04
Date Added to Maude2018-01-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationSERVICE PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactADAM FORESMAN
Manufacturer Street675 HEATHROW DRIVE
Manufacturer CityLINCOLNSHIRE IL 60069
Manufacturer CountryUS
Manufacturer Postal60069
Manufacturer Phone2242204329
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameJB-70
Generic NameUNIT, X-RAY, EXTRAORAL WITH TIMER
Product CodeEHD
Date Received2018-01-11
Model NumberJB-70
Catalog NumberI7017G
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORPORATION
Manufacturer Address675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US 60069


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-11

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