MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-22 for ZXT RADIATION THERAPY TREATMENT TABLE 9820952 NA manufactured by Siemens Medical Solutions Usa, Inc..
[22181552]
It was reported that the treatment table moved upwards without command from the operator. The system did display an error message to the user when the uncommanded movement occurred. However, the user cleared the error messages and continued to operate the system. The user's manual clearly states that when this error message occurs, the user should "remove the pt and call service". The investigation showed that this issue occurred due to a firmware malfunction. It is important to note that the red emergency stop button which halts all system movement remains functional if this problem occurs. Although this issue occurred during a pt treatment, there was no reported injury associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2006-00014 |
| MDR Report Key | 871270 |
| Report Source | 05,06 |
| Date Received | 2006-09-22 |
| Date of Report | 2004-10-21 |
| Date of Event | 2004-10-21 |
| Date Mfgr Received | 2004-10-21 |
| Date Added to Maude | 2007-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAN TAKEMOTO |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9256028192 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2910081-06/26/06-001C |
| 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 | 2006-09-22 |
| Model Number | 9820952 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 851847 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-22 |