MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS; INNOVA 2100-IQ

Device Problems Loss of Power (1475); Failure to Power Up (1476); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802)

Event Date 09/09/2020

Event Type  Death  

Manufacturer Narrative

The customer is not allowed to provide patient information per hippa regulations.Customer contact address e-mail was not provided.Ge's healthcare investigation is ongoing.A follow-up report will be submitted when the investigation is completed.

Event Description

A patient unstable arrived at the hospital with symptoms of infarction.During the examination the system suddenly shut down, and despite several reboot attempts, it was not possible to continue the procedure.The medical staff tried to stabilize the patient, but he coded, and despite life saving measure he did not survive.Gehc became aware of this event when the customer, who was without a service contract, got in touch seeking to regularize his contract with the gehc commercial team for later scheduling of visits to diagnose the cause of the reported problem.

Manufacturer Narrative

On (b)(6)2020 , customer reported that the system lost motion with a patient on table on (b)(6)2020.To attempt to recover the gantryâ¿¿s motion the operator rebooted the system, instead of the expected auto or manual reverse motion used to normally clear a contact with collision sensors.At the same period the severely ill patient fell into cardiac arrest.Despite lifesaving cardiopulmonary efforts during the reboot cycle, the patient expired.System log analysis shows that there were cascading use errors.1) customer did not reboot the system for 2 months despite warning messages in each use.2) in this situation, the collision-sensors identified contact between tube and table and the user did not appropriately clear them.3) the positioner needed to be backed away.4) instead, the operator chose to do a complete reboot which cannot clear a collision.The patient expired during the first reboot cycle as a consequence of their underlying cardiac arrest for which the attempted life saving measures did not require fluoroscopy.Subsequently, there was a pc bios battery end-of-life failure which prevented reboots.This failure could have been detected during the common daily reboot check as recommended in the product labeling.No usability concern has been identified.The customer was able to recover after system reset and gantry motion to clear the collision.On (b)(6)2020 , fe replaced the batteries as preventive action.He reminded also the customer to shut down the system daily and show how to clear the collision.No further actions are necessary.

• Type of Device: INNOVA 2100-IQ
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 10625534
• MDR Text Key: 209743013
• Report Number: 9611343-2020-00004
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K052412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death