PREVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for PREVA manufactured by Midmark Corporation.

Event Text Entries

[105679009] On (b)(6) 2018 it was reported to midmark by a service technician than an x-ray unit (preva, 76" reach, serial number (b)(4)) separated from the wall in which it was secured. There were no injuries or contact with any persons as reported by the complainant. No other patient information has been disclosed. The unit mounting was visually inspected at the user facility by the technician and photographs were sent to midmark. The technician suspects there to be wood splitting ("stud split"), however, after removal of the drywall at the location where the unit was mounted, it was discovered that the top lag bolt did not fully penetrate the stud to the depth required to support the weight of the preva as is required per the midmark preva installation manual. Information obtained by midmark technical service during the call indicates the following: it is unknown if the structure has been modified in any way, the wall mounting is a single stud wall mount, the midmark installation guide was not used during install, the studs are not exposed, and the unit has a 76" reach in total. Conditions at the time of install are unknown. The unit was manufactured 03/11/2011 and shipped on (b)(6) 2011. Per the information obtained from the technician, the top lag bolt came loose from the wall (unbroken) while the bottom lag bolt remained secured to the wall. No other surfaces were damaged by the separation. Minor drywall damage to the wall was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423380-2018-00002
MDR Report Key7426531
Date Received2018-04-12
Date of Report2018-04-12
Date of Event2018-03-16
Date Mfgr Received2018-03-16
Device Manufacturer Date2011-03-11
Date Added to Maude2018-04-12
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 NamePREVA
Generic NameUNIT, X-RAY, INTRAORAL
Product CodeEAP
Date Received2018-04-12
Model NumberPREVA
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 2018-04-12

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