EXACT COUCH NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-03 for EXACT COUCH NA manufactured by Varian Medical Systems.

Event Text Entries

[14868040] When the radilogical tech tried to retract the couch top longitudinally to remove the pt from the couch, the tech pinched and broke the little finger of his left hand in a pinch point of the underside of the exact couch. The pinch point seemed to be the gap between the underside of the couch top and the lateral carriage.
Patient Sequence No: 1, Text Type: D, B5


[15227573] H6: this incident has been recognized as user error by varian med systems. Labeling placed on the couch, as well as in the user manual, provide instruction and hazard warnings (with respect to hand placement), which help to ensure the safe operation of the equipment.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2914292-2006-00038
MDR Report Key767173
Report Source05,06
Date Received2006-10-03
Date of Report2006-09-08
Date of Event2006-09-07
Date Mfgr Received2006-09-15
Date Added to Maude2006-10-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDALE REYNOLDS
Manufacturer Street911 HANSEN WAY-M/S C255
Manufacturer CityPALO ALTO CA 94304
Manufacturer CountryUS
Manufacturer Postal94304
Manufacturer Phone6504246640
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXACT COUCH
Generic NamePT POSITIONING TABLE
Product CodeJAI
Date Received2006-10-03
Model NumberEXACT COUCH
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key755073
ManufacturerVARIAN MEDICAL SYSTEMS
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-10-03

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