PREVA P7017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-06 for PREVA P7017 manufactured by Midmark Corporation.

Event Text Entries

[102096792] On 2/7/2018 it was reported to midmark by a service technician that an z-ray unit (preva, 76" reach, serial (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 and photographs were provided to midmark. There is evidence of wood splitting in the photographs provided. Per the questionnaire completed by technical support while on the initial call with the service technician, no installation manual was used for this installation. The preva unit (dom (b)(6) 2007) was mounted to the wall through drywall using a single stud mount. Per the questionnaire, the top lag bolt split the stud and came loose (unbroken) from the wall while the bottom lag bolt remained secured in the stud. The wall fasteners were not centered in the wall stud. No other surfaces at the location were damaged aside from the unit itself. Multiple attempts to contact the initial reporter went unanswered. Midmark technical support made attempts to contact the initial reporter on 2/7/2018, 2/19/2018, and 2/26/2018 with no response. On 3/6/2018, technical support contacted the customer directly to inquire as to the status of the unit. The customer informed midmark at that time that the unit has not yet been remounted at their location. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423380-2018-00001
MDR Report Key7319042
Date Received2018-03-06
Date of Report2018-02-19
Date of Event2018-02-07
Date Mfgr Received2018-02-07
Device Manufacturer Date2007-08-01
Date Added to Maude2018-03-06
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 Received2018-03-06
Model NumberPREVA
Catalog NumberP7017
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 2018-03-06

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