VARIAN 21EX WITH OBI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-30 for VARIAN 21EX WITH OBI manufactured by Varian.

Event Text Entries

[21424134] The date of the event above reflects the onset date. The event has not ended, but continues. A neighborhood electrical cable upgrade was completed. Preceded by two discontinuous but similar events two days later, a low frequency pulse began, coming from the direction of medical center. I live within a few hundred feet of the street entrance to the hospital in a 3-story wooden home, on a bedrock upslope that begins across the street. Grates along the street side of the hospital vent heat buildup from the hospital's 3 varian linear accelerators. Their oncology setup also includes a ge light-speed ct simulator, and an imrt -intensity modulated radiation therapy- unit for imaging. Noise emits from the grates continuously as does a whine from the specialized circuit breaker white metal box above the grate adjacent to the hospital's entrance. There is also an infrasound cancer research facility in a building less than a hundred feet from my home, topped with rooftop cryogenics units which caused the entire building to whine after the power upgrade. The latter issue seems to have been addressed, as the noise stopped the night after i forced a hospital engineer to investigate. The hospital asked for the power upgrade and has been contacted along with local officials. In fact, i remain in weekly contact with the hospital's community liaison. The hospital refuses to admit any culpability and typically redirects complaints by blaming other parties, like the department of public works -defective street lamps. I believe the source of the powerful pulse is radio frequency noise -rf---due to improper shielding, insufficient capacitors for heat shielding, imaging device interference, or transitory structural vibration in the ilfm ranges. I am unable to sleep, as the pulse is strongest at night. It is audible to me for 16 out of 24 hours a day and can't be blocked by earplugs or similar barriers. This has been occurring for 31 nights straight. White noise, cycling at 3 hz, played through earphones has helped me sleep the past three nights, uncomfortably. However, the fatigue persists and a headache at the back of my head above my spine between my ears is now ever present. It is as if any barrier to the pulse is only a temporary panacea. I also experience earaches with occasional popping. Dates of use: 2009.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5013774
MDR Report Key1550743
Date Received2009-11-30
Date of Report2009-11-30
Date of Event2009-10-31
Date Added to Maude2009-12-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameVARIAN 21EX WITH OBI
Generic NamePLATINUM LINEAR ACCELERATOR TRIOLOGY RADIOTHERAPY
Product CodeIYE
Date Received2009-11-30
Model Number21EX WITH OBI
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerVARIAN

Device Sequence Number: 2

Brand NameVARIAN
Generic NameTRIOLOGY RADIOTHERAPY
Product CodeKPQ
Date Received2009-11-30
OperatorHEALTH PROFESSIONAL
Device Sequence No2
Device Event Key0
ManufacturerVARIAN


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2009-11-30

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