RAYCELL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-01-07 for RAYCELL manufactured by Best Therataronics.

Event Text Entries

[18965178] Best theratronics was performing a preventive maintenance inspection and discovered low x-ray output readings at 2 points inside the canister near the upper x-ray tube. All other points were within acceptable limits. The use of rad-sure 25 gy radiation indicator devices inside the canister did not detect the low output.
Patient Sequence No: 1, Text Type: D, B5


[19116224] A leak from the coolant system (not provided by best theratronics) appears to have caused corrosion and leached inside the x-ray chamber. The corrosive material became deposited on the x-ray filter and partially blocked the beam. The cause of the leak is not known. This is the first report of this type of problem. Two other x-ray units at the same facility were inspected and found to have acceptable outputs. There was evidence of a previous small leak (drop) on one unit but no visible indications of corrosion that was seen on the original unit.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006946288-2010-00001
MDR Report Key1577785
Report Source07
Date Received2010-01-07
Date of Report2010-01-07
Date of Event2009-12-04
Date Mfgr Received2009-12-04
Device Manufacturer Date2008-06-01
Date Added to Maude2010-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMIKE DE VAN DER SCHUEREN, DIR
Manufacturer Street413 MARCH ROAD
Manufacturer CityOTTAWA, ONTARIO K2K 0E4
Manufacturer CountryCA
Manufacturer PostalK2K 0E4
Manufacturer Phone5912100
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAYCELL
Generic NameRAYCELL
Product CodeMOT
Date Received2010-01-07
Model NumberRAYCELL
OperatorHEALTH PROFESSIONAL
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBEST THERATARONICS
Manufacturer AddressOTTAWA, ONTARIO CA


Patients

Patient NumberTreatmentOutcomeDate
10 2010-01-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.