MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-09-08 for ZXT TABLE * manufactured by Siemens Medical Systems / Oncology Care Systems.
[20990624]
Report indicated that the treatment table moved on its own after locking up. Investigation revealed that inadvertent movement is associated with table lockup, a phenomena which disrupts table control and halts all table movement. Recovery from table lockup would normally be through the use of the motion stop reset at the control console. However, some users have discovered that pressing the deadman switch on the main overhead hand control would also restore table movement. It is after such action that the table may move without further command. Users are being advised not to use the overhead hand control deadman method to recover from table lockup. A field correction will be implemented to address this issue and prevent table lockup and unexpected movement. There was no injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2000-00006 |
| MDR Report Key | 295137 |
| Report Source | 05,07 |
| Date Received | 2000-09-08 |
| Date of Report | 2000-09-05 |
| Date of Event | 2000-07-24 |
| Date Mfgr Received | 2000-07-24 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-09-13 |
| 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 | EWALD RIECHERT |
| 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 |
| Removal Correction Number | (806.10) |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZXT TABLE |
| Generic Name | PATIENT SUPPORT SYSTEM |
| Product Code | JAI |
| Date Received | 2000-09-08 |
| 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 | 285667 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS / ONCOLOGY CARE SYSTEMS |
| Manufacturer Address | 4040 NELSON AVENUE 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 | 2000-09-08 |