MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 530

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information not applicable.No report of patient involvement.Initial reporter email address not provided.Date of device manufacture will be provided in follow up report.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

On august 07, 2020, customer from (b)(6), reported to ge healthcare (gehc) field service engineer (fe) that the monitor suspension was difficult to handle.The ge healthcare (gehc) field service engineer (fe) during the examination of the issue reported that the mounting rails of the monitor suspension were loose from the ceiling and present a potential risk of monitor suspension fall.There is no patient impact, there was no complete fall of the suspension, but it lowered down from the ceiling of about ~2cm on 1 side of the left rails.The gehc fe immediately secured the suspension by moving it on the right side not damaged and the room was closed by the costumer to not allow any usage of the vascular system.A detailed analysis of the root cause will be provided in the follow up report.

Manufacturer Narrative

On (b)(6)2020 ge healthcare field service engineer observed that the mounting rails of the monitor suspension were loose from the ceiling.The suspension did not fall and no patient impact was reported.Nevertheless, this issue could potentially lead to the fall of the entire suspension.Ge healthcare engineering investigation of this event was performed using information provided by ge healthcare field service engineer and from the systemâs pre-installation manual.It has been found that the monitor suspension was difficult to handle and translate into the rail, because 2 fixing points (anchors) were pulled out from the ceiling.Investigation concludes that the number of anchors to sustain the load of the suspension was not compliant with ge installation requirements.This modification was made during the installation of the large display monitor.It has been confirmed that this is a site specific issue and an isolated case.Ge healthcare pre-installation manual provides all necessary information for a proper installation.The site correction is in progress.Customer is employing a structural engineer to redesign the upper structure and to reaffix the suspension.A follow-up report will be submitted when the correction will be done.

Manufacturer Narrative

The site correction was led by the customer and a 3rd party contractor.On (b)(6) 2021, a stainless steel structure was installed, which was validated by gehc mechanical engineering team.No further action from gehc is needed.

• Brand Name: INNOVA IGS 530
• Type of Device: INNOVA IGS 530
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 10481671
• MDR Text Key: 214824081
• Report Number: 9611343-2020-00001
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K122457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1