DEFINIUM 8000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-18 for DEFINIUM 8000 manufactured by Ge Medical Systems, Llc.

Event Text Entries

[2513558] It was reported that a pt barrier rotational handle lock was broken in a manner that prevented it from locking into position. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[9593179] This malfunction was determined to be reportable as this same malfunction was previously contributed to a serious injury within the last two years. Reference mdr 2126677-2010-00010. Initial reporter occupation was not provided. Ge healthcare's investigation concluded that the mechanism which applies friction to the definium 8000 pt barrier pivoting arm wears rapidly allowing the arm to swing freely when the lock is not applied. The result is that the pivoting arm may be stored in an upright position which will be unstable due to a lack of residual friction. Ge healthcare will modify the rotating arms to restore the residual friction so that the arm will retain position (rather than swing freely) while the locking levers are disengaged. The product labeling will also be updated to improve awareness and identify the hazard relative to proper storage. This action has been reported to fda per 21 cfr part 806 on 1005/2011. Reference corrections and removals report number 2126677-10/5/11-002-c.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2126677-2012-00007
MDR Report Key2436797
Report Source06
Date Received2012-01-18
Date of Report2012-01-11
Date of Event2012-01-11
Date Mfgr Received2012-01-11
Device Manufacturer Date2006-02-01
Date Added to Maude2012-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJOY SONSALLA
Manufacturer Street3000 N GRANDVIEW BLVD. W450
Manufacturer CityWAUKESHA WI 53188
Manufacturer CountryUS
Manufacturer Postal53188
Manufacturer Phone2625482661
Manufacturer G1GE MEDICAL SYSTEMS, LLC
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2126677-10/5/11-002-C
Event Type3
Type of Report3

Device Details

Brand NameDEFINIUM 8000
Generic NameSTATIONARY X-RAY SYSTEM
Product CodeIZF
Date Received2012-01-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer AddressWAUKESHA WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-01-18

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