MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 530; INTERVENTIONAL FLUOROSCOPIC X-RAY

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not applicable.No report of patient involvement.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 diagnostic procedure, the ceiling monitor suspension rails have detached from the ceiling from the back end and entire monitor suspension assembly almost fell onto the floor.There was no report of any injury.Diagnostic procedure was completed successfully.

Manufacturer Narrative

On (b)(6) 2017 customer reported to ge healthcare field service engineer that the ceiling monitor suspension rails detached from the ceiling at the back end and almost fell onto the floor.This event occurred during an exam but patient was not hit and no injury was reported.The doctor was able to secure the patient, and the monitors were still working hence the procedure has been completed successfully.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 customer ceiling broke and monitor suspension along.The ceiling structure that supports the monitor suspension was owned and built by the customer.Ge healthcare pre-installation manual provides all necessary load and dimensional details for proper building of the ceiling structure.Ge healthcare installation team confirmed that they handed over all these details to the customer.The investigation concluded that the customer did not follow the instructions provided in the pre-installation manual.Indeed, he did not ensure about the ceiling strength that was not in line with ge healthcare specifications to withstand the weight of the suspension.Neither malfunction nor defect has been identified with the design, assembly or manufacture of the system.The site correction is in progress: customer is employing a structural engineer to redesign the upper structure.A supplemental report will be submitted when correction is completed.

• Brand Name: INNOVA IGS 530
• 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: 6871591
• MDR Text Key: 86604005
• Report Number: 9611343-2017-00011
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K122457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• 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
• Date Manufacturer Received: 08/23/2017
• 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