MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY

Device Problems Break (1069); Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Operator of device not applicable.Room was not in use and no one was in the room.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation is completed.Device evaluation anticipated, but not yet begun.

Event Description

During a service intervention on the system, ge healthcare field service engineer noticed that the grout pad on which the c-arm base plate is fixed was broken.This condition could lead to a partial or complete fall of the entire gantry assembly.The gantry assembly is currently intact and did not fall.There was no report of any injury and no report of patient involvement.

Manufacturer Narrative

Block has been updated.510(k): k092004.Device manufacturer date: 11/05/2010.No injury was reported.Investigation of this event was performed using information provided by gehc field service engineer and system pre-installation manual.When he visited the customer site ge healthcare field service engineer noticed that the gantry was visually lifted off the floor by 7 mm.He stopped the system for usage citing risk of gantry fall and removed the gantry from the floor.He observed that the grout pad was broken and the chemical anchors pulled out from concrete.This system was installed on (b)(6) 2011 by ge healthcare field service engineer.Chemical anchors that were locally procured were used to fix the gantry.During the installation, ge healthcare field service engineer drilled excessive diameter holes on the concrete for the anchors.Pre-installation manual contains appropriate installation kit specification.It also instructs to involve structural engineers for installation of gantry to the floor.It was confirmed that this inappropriate installation is an isolated case.The root cause of this issue is an installation error isolated to this system since instructions were not followed during installation.Gantry installation instructions have been reviewed and found to be appropriate, and all necessary tools are also provided with the system for correct installation.It cannot be determined why initial ge healthcare field service engineer did not use anchors provided with the system and drilled excessive diameter holes since he left ge healthcare in between.System was corrected on (b)(6) 2017.No further action is required.

• Brand Name: INNOVA 3100-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc ; FR
• Manufacturer Contact: angele taormina ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 6597730
• MDR Text Key: 76289568
• Report Number: 9611343-2017-00008
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: 05/02/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 05/02/2017
• Supplement Dates FDA Received: 11/03/2017
• Date Device Manufactured: 11/05/2010
• 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