MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS ADVANTX; ADVANTX LCA+

Device Problems Break (1069); Component Falling (1105); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during the boot-up phase of the system, an operator noticed that the camera housing was broken and that the camera head was hanging by its cable.The room was not used at that time and no one was present in the room when the camera fell.There was no report of any injury and no report of patient involvement.

Manufacturer Narrative

On february 28, 2017 customer reported to ge healthcare field service engineer that the camera of the image intensifier was hanging on its cables.It was confirmed that the camera did not fall on the table.This issue occurred, and was discovered, while nobody was present in the room.This incident occurred on an advantx-e system installed on (b)(6) 2002 on a previous site and moved to this site on (b)(6) 2013.It was de-installed on this site on (b)(6) 2017.No injury has been reported.Ge healthcare engineering investigation of this event was performed using information provided by ge healthcare field service engineer and system pre-installation manual.Ge healthcare field service engineer confirmed that the plastic part joining the camera to image intensifier (nose cone) broke between the cover screws.This part ¿nose cone¿ is a bridge between the camera and image gate.Thus the breakage of this lead to a complete fall of the camera, hanging on its cables.The investigation concluded that the camera head broke from the support base due to collision with an external object caused by a user of the system.Instructions are clearly provided in operator manual to ensure the equipment path is clear before starting a motion and while positioning the equipment, to carefully observe the moving parts and stop the motion before making any contact.No customer reminder has been deemed necessary since system is now de-installed.Based on this analysis, neither corrective nor preventive action has been deemed necessary, and no further action is required.

• Brand Name: ADVANTX
• Type of Device: ADVANTX LCA+
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc ; FR
• Manufacturer Contact: elodie fins ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 6449113
• MDR Text Key: 71587213
• Report Number: 9611343-2017-00005
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1