MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 4100-IQ

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)

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

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

No patient has been involved in this issue.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation is completed.The radiation shield suspension and its substructure are designed and manufactured by aadco (original equipment manufacturer) and is an accessory of the system.A first root cause analysis showed that this issue may be due to an improper installation.A deeper analysis of this issue is still in progress, and further information will be provided as part of the final report.Device evaluation anticipated, but not yet begun.

Event Description

Ge healthcare field service engineer observed that the radiation shield suspension rails were not correctly fixed to the ceiling.The suspension rails is manufactured by aadco.The suspension did not fall and there was no report of any patient impact.Nevertheless, it has been confirmed on (b)(4) 2019 that this issue could potentially lead to a fall of the entire suspension.

Manufacturer Narrative

Block h6: on (b)(6) 2019 customer felt some issue with suspended radiation shield track and requested to ge healthcare (gehc) field service engineer (fe) to inspect the ceiling track.Adcoo, and not gehc, is the manufacturer of the suspension rails, and the radiation shield track.On (b)(6) 2019 ge healthcare field service engineer observed that the radiation shield suspension rails were not correctly fixed to the ceiling.The suspension did not fall and there was no report of any patient impact.Nevertheless, per the communication with aadcoo 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 gehc field service engineer and from installation instructions for ceiling track provided by aadco.It has been found that the ceiling track had a weldment damage.Those weldments are used to join the plates to the tacks.The root cause of the weldment damage could be the improper installation of the ceiling track.The track was attached to the roof with six screws instead of the eight as recommended in the installation instructions.Aadco installation instructions for ceiling track provides all necessary information for a proper installation.It has been confirmed that this is a site specific issue and isolated case.On (b)(6) 2019, aadco was alerted of the issue by ge healthcare.On (b)(6) 2019 aadco agreed to take the appropriate actions, i.E.Sending a letter to customer recommending to stop usage of the suspension, replace the ceiling track and the radiation shield by a new one etc.No further action from gehc is needed.

• Brand Name: INNOVA 4100-IQ
• Type of Device: INNOVA 4100-IQ
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 8711642
• MDR Text Key: 148408893
• Report Number: 9611343-2019-00005
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1