MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 2000; INTERVENTIONAL FLUOROSCOPIC X-RAY,

Model Number XCA106

Device Problems Intermittent Continuity (1121); Image Resolution Poor (1306); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969)

Event Date 12/25/2016

Event Type  Death  

Manufacturer Narrative

The patient id is (b)(6) (put it in this section since the patient id cannot be more than 10 characters).Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported to ge healthcare that a patient was admitted to hospital with acute myocardial infraction (ami) on (b)(6) 2016.During an exam performed on (b)(6) 2016, the fluoroscopy imaging mode failed resulting in the inability to visualize the area.The patient was transferred to an adjacent exam room to complete the procedure.The patient expired during transfer on (b)(6) 2016.Customer declined to provide more information on this adverse event to ge healthcare.

Manufacturer Narrative

Date of report was updated to (b)(6) 2017.Investigation of this event was performed using information provided by ge healthcare field service engineer and logs from the system.On (b)(6) 2016 it was reported that the patient went to hospital with an acute stemi (segment elevation myocardial infarct) on (b)(6) 2016.The fluoroscopy failed during exam.Some period after the loss of imaging mode, patient was transferred to an adjacent room.During transfer to adjacent angiography suite, patient expired.No further details are known and unknown from customer if image failure contributed to patient outcome.It was concluded that the system contribution to the patient outcome cannot be determined with the low level of information provided by the hospital.It was concluded that the most probable root cause of the issue was an aging of the wire for x-ray tube pump supply (one of the 4 wires of xj212 plug (the one that supplies x-ray tube oil pump) was weakened at the metal crimp end and finally broke when this plug was disconnected and reconnected.The oil pump was no more supplied and then did not pump oil and cool anymore x-ray tube, leading to x-ray tube overheating and 70°c thermal switch opening).The system was temporarily repaired by soldering the wire to the connector on (b)(6) 2016.Defective cable shall be replaced to permanently fixed this issue as a correction but due to the exam room availability, this cable has not been replaced yet.

Manufacturer Narrative

On august 21, 2017 ge healthcare field service engineer permanently repaired the defective cable by using a specific repair kit, which fixed the issue.It was not possible to replace the defective cable since it would require a construction work and customer decided not to give access for such work.No further action is required.

• Brand Name: INNOVA 2000
• 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: 6278777
• MDR Text Key: 65775531
• Report Number: 9611343-2017-00002
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: XCA106
• 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: 12/29/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 89