MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for FIXED IMAGING EQUIPMENT manufactured by Siemens Medical Solutions Usa, Inc..
[182352728]
Siemens imaging system error identified prior to placing patient on table for procedure. Engineering determined that siemens representative needed to diagnose and troubleshoot computer hardware problem. Patient moved back to holding area with plan to wait and see if it gets fixed and reschedule otherwise. Lack of alternative hybrid room availability likely means that we cannot accept ruptured aneurysms. This is second time this has happened to one of my patients within the last 3 weeks (last patient was anesthetized when the issue was identified), and therefore should be viewed as a pattern rather than an isolated event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9798446 |
| MDR Report Key | 9798446 |
| Date Received | 2020-03-06 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-07-02 |
| Report Date | 2019-12-09 |
| Date Reported to FDA | 2019-12-09 |
| Date Reported to Mfgr | 2020-03-06 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXED IMAGING EQUIPMENT |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2020-03-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |