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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC RFX/SFX TABLE, X-RAY, RFX CLASSICAL

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GE MEDICAL SYSTEMS, LLC RFX/SFX TABLE, X-RAY, RFX CLASSICAL Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105); Noise, Audible (3273)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare¿s investigation has completed and the root cause of the crt monitor detaching was determined to be degradation of the monitor¿s support feet due to age. The site was corrected through replacement of the newly designed metal monitor support feet. No further actions are needed. During investigation, it was also identified this monitor suspension was not included in the original customer installed base list related to corrections and removals report number 3007734888-12/01/16-001-c. It was determined this monitor suspension was de-installed at another site by a third party and therefore removed from ge installed base tracking. (b)(6) clinic stated they had purchased the monitor suspension from a third party who also installed the suspension. Since ge healthcare does not perform the service maintenance at (b)(6) clinic and was not made aware of the third-party installation, it was not included in the corrections and removal customer installed base list. This monitor suspension has since been added to ge healthcare's installed base tracking. No further actions are needed. This action was reported to fda per 21 cfr part 806 on 01-dec-2016 through corrections and removals report number 3007734888-12/01/16-001-c.
 
Manufacturer Narrative
Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed.
 
Event Description
On (b)(6)2017, the technologist at (b)(6) in the united states reported they heard a loud noise that came from the radiology exam room. When the technologist investigated the noise, they identified the crt monitor detached from the monitor suspension and was hanging from the suspension by the power cables. There was nobody within the exam room when the monitor fell and there was no injury related to this event.
 
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Brand NameRFX/SFX
Type of DeviceTABLE, X-RAY, RFX CLASSICAL
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 north grandview boulevard
waukesha, WI
Manufacturer Contact
anne krueger
3000 north grandview boulevard
waukesha, WI 
MDR Report Key6761696
MDR Text Key253574630
Report Number2126677-2017-00009
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K760466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Radiologic Technologist
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUDI NOT REQUIRED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number3007734888-12/01/16-001C

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