MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-24 for 9900 manufactured by Ge Oec Medical Systems, Inc.
[172679368]
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.
Patient Sequence No: 1, Text Type: N, H10
[172679369]
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.
Patient Sequence No: 1, Text Type: D, B5
[184390781]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720753-2019-00001 |
| MDR Report Key | 9517284 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-24 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-12-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TROY PERRY |
| Manufacturer Street | 384 N WRIGHT BROTHERS DR |
| Manufacturer City | SALT LAKE CITY UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9900 |
| Generic Name | FLUOROSCOPIC X-RAY |
| Product Code | JAA |
| Date Received | 2019-12-24 |
| Model Number | 9900 |
| Lot Number | ES-7277-CMH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE OEC MEDICAL SYSTEMS, INC |
| Manufacturer Address | 384 N WRIGHT BROTHERS DR SALT LAKE CITY, UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-12-24 |