DISCOVERY XR650

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 2011-03-31 for DISCOVERY XR650 manufactured by Ge Medical Systems, Llc.

Event Text Entries

[1847586] It was reported that a pt barrier rotational handle lock was broken. No injury was reported. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5


[9185295] This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury within the last two years. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2126677-2011-00022
MDR Report Key2068338
Report Source05,06
Date Received2011-03-31
Date of Report2011-03-31
Date of Event2011-03-04
Date Mfgr Received2011-03-04
Date Added to Maude2011-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISCOVERY XR650
Generic NameX-RAY SYSTEM
Product CodeIZF
Date Received2011-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer AddressWAUKESHA WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-31

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