EUREKA TUBE STAND PM 4000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-09-01 for EUREKA TUBE STAND PM 4000 * manufactured by Continental, C/o Hologic, Inc..

Event Text Entries

[452576] X-ray tube stand assembly dislodged from ceiling track when tube was rotated to a 90 degrees. Tube assembly then fell forward off bottom rail assembly striking the x-ray table. No pt was involved in this incident, therefore there was no pt injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221300-2005-00002
MDR Report Key672250
Report Source00
Date Received2005-09-01
Date of Report2005-08-22
Date of Event2005-07-19
Device Manufacturer Date1995-08-01
Date Added to Maude2006-02-09
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 ContactLINDA REED
Manufacturer Street35 CROSBY DRIVE
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal01730
Manufacturer Phone*
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEUREKA TUBE STAND
Generic NameDIAGNOSTIC X-RAY TUBE MOUNT
Product CodeIYB
Date Received2005-09-01
Model NumberPM 4000
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key661575
ManufacturerCONTINENTAL, C/O HOLOGIC, INC.
Manufacturer Address* * *
Baseline Brand NameEUREKA TUBE STAND
Baseline Generic NameDIAGNOSTIC X-RAY TUBE MOUNT
Baseline Model NoPM 4000
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-09-01

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