MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2001-08-31 for ZXT TABLE * manufactured by Siemens Medical Systems Oncology Care Systems.
[209868]
Table vertical up movement without command from any person. The table base filled with water because of water leakage at the pumpstand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2001-00004 |
| MDR Report Key | 350273 |
| Report Source | 01,05,07 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-31 |
| Date of Event | 2001-08-03 |
| Date Mfgr Received | 2001-08-03 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2001-09-10 |
| 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 | G. BUTCHER |
| 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 | 2001-08-31 |
| Model Number | ZXT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 339562 |
| 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 | 2001-08-31 |