MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC 9900; FLUOROSCOPIC X-RAY

Model Number 9900

Device Problems Communication or Transmission Problem (2896); Insufficient Information (3190); Intermittent Communication Failure (4038)

Patient Problem Death (1802)

Event Date 12/08/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare¿¿s investigation into the reported occurrence is ongoing.A follow-up report will be submitted when the investigation has been completed.Patient information could not be obtained after multiple attempts.

Event Description

The customer reported that a patient required an emergency coronary procedure to place multiple cardiac stents.During the procedure the system displayed an error message and lost functionality.The facility did not have an available backup unit.The surgeon chose to terminate the procedure and transport the patient to another facility.The patient expired prior to being able to transport them to another facility.

Manufacturer Narrative

Ge healthcare's investigation into the reported event is now complete.Prior to the adverse event on (b)(6) 2019, log file analysis and system cycling data indicate that the system displayed the same overload fault error message on 25-nov-2019, and had to be rebooted multiple times.Field service engineers (fses) visited the site multiple times to diagnose the issue, however no repairs were made.After the adverse event, it was concluded that the overload fault errors were the result of normal wear and tear on the x-ray tube, which was more than 7 years old.In response to the 25-nov-2019 complaint, the system was not properly evaluated as described by the 9900 service manual.The prescribed troubleshooting and testing processes were not followed, which resulted in the x-ray tube not having been replaced.The failure to replace the x-ray tube to address the first reported overload fault errors resulted in the continued use of the system by the customer and the repeat of those same errors on 08-dec-2019.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers dr; salt lake city, UT 84116
• Manufacturer Contact: troy perry ; 384 n wright brothers dr; salt lake city, UT
• MDR Report Key: 9517284
• MDR Text Key: 172679368
• Report Number: 1720753-2019-00001
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9900
• Device Lot Number: ES-7277-CMH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 60