MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-12-19 for ZXT TABLE * manufactured by Siemens Medical Systems/oncology Care Systems.
[18193621]
"during pt setup therapist was pressing the vertical up switch and deadman control panel in zxt. He released both sw when table is reached proper position, but the table still moved upward itself. So the operator was upset, tried to make motion stop and at the same time he moved the table top to the left, in that moment, pt's breast got a slight hit by the electron cone. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2000-00008 |
| MDR Report Key | 309930 |
| Report Source | 05,07 |
| Date Received | 2000-12-19 |
| Date of Event | 2000-11-24 |
| Date Mfgr Received | 2000-12-04 |
| Date Added to Maude | 2000-12-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KITTY DODD |
| Manufacturer Street | 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9252468200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZXT TABLE |
| Generic Name | PATIENT SUPPORT SYSTEM |
| Product Code | JAI |
| Date Received | 2000-12-19 |
| Model Number | ZXT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 299848 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS/ONCOLOGY CARE SYSTEMS |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US |
| Baseline Brand Name | ZXT TABLE |
| Baseline Generic Name | PATIENT SUPPORT SYSTEM |
| Baseline Model No | ZXT |
| Baseline Device Family | MEVATRON LINEAR ACCELERATOR SYSTEMS |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | 120 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910971 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-12-19 |