MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-12-21 for ZXT RADIATION THERAPY TREATMENT TABLE 04474354 manufactured by Siemens Medical Solutions Usa, Inc..
[536254]
Pt was on table when error occurred, however, no physical event to pt occurred. There is a potential for unintended motion of the table after an interlock (e17) has occurred, and the user attempts to reinitiate the system. The user manual instructs the user to remove pt and call service when this error (interlock) occurs (see attached pages from user manual). In this case the user left the pt on the table, and attempted to reinitiate the table which in turn caused unintended motion upward, the motion was stopped by emerging off.
Patient Sequence No: 1, Text Type: D, B5
[7988627]
A firmware revision is planned to further mitigate the potential for unintended motion after an interlock e17 has occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2004-00002 |
| MDR Report Key | 779941 |
| Report Source | 07 |
| Date Received | 2004-12-21 |
| Date of Report | 2004-12-17 |
| Date of Event | 2004-10-21 |
| Date Mfgr Received | 2004-10-21 |
| Date Added to Maude | 2006-11-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEN NEHMER |
| 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 | PENDING |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZXT RADIATION THERAPY TREATMENT TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2004-12-21 |
| Model Number | NA |
| Catalog Number | 04474354 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 767710 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | * CONCORD CA * US |
| Baseline Brand Name | ZXT RADIATION THERAPY TREATMENT TABLE |
| Baseline Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Baseline Model No | NA |
| Baseline Catalog No | 04474354 |
| Baseline ID | NA |
| Baseline Device Family | ZXT TABLE |
| Baseline Shelf Life [Months] | NA |
| 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 | 2004-12-21 |