MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-16 for ARTIS OR TABLE manufactured by Siemens Medical Solutions Usa, Inc..
[82786511]
Patient Sequence No: 1, Text Type: N, H10
[82786512]
Patient on x-ray table in operating room for a transcatheter aortic valve replacement (tavr) procedure. Patient was already sedated and prepped. Doctor attempted to move table and use fluoro machine to provide visual assistance for femoral puncture. Error message was received from table. Radiology technician called and rebooted machine. Error message persisted - seimens contacted and informed staff that error message would require on-site attention. Tavr case cancelled along with two other tavr cases scheduled for the same day. Additional information from patient safety report: first patient had to be awakened and informed of cancellation of procedure. Second patient already here waiting. Equipment failure has resulted in cancellation and rescheduling of tavr procedure. This has occurred at least five other times over the last four years. The equipment needs to be replaced if this is going to be an on-going issue as it negatively affects patient safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6796761 |
| MDR Report Key | 6796761 |
| Date Received | 2017-08-16 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-08-07 |
| Report Date | 2017-08-08 |
| Date Reported to FDA | 2017-08-08 |
| Date Reported to Mfgr | 2017-08-08 |
| Date Added to Maude | 2017-08-16 |
| 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 |
| 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 | ARTIS OR TABLE |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | KXJ |
| Date Received | 2017-08-16 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | ROBERT PHILLIPS 40 LIBERTY BOULEVARD, MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-16 |