MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2007-05-07 for 550 TXT TREATMENT TABLE 07346534 manufactured by .
[20345722]
A product problem was reported with our treatment table. After treatment session was completed, the operator was lowering the table top by using a hand control device to allow patient dismount. The table abruptly stopped and the operator attempted to lower the table again by using the hand control device. The table top suddenly dropped approximately 10cm without producing an interlock during non-treatment state. Root cause on the sudden vertical drop has not been determine and is currently under investigation. No injury was reported as a result of this incident. It's important to note, by design system will trigger an interlock if table drops beyond specification during treatment. In addition, the 10cm drop was not measured with a calibrated device or based on captured data from the system, and only an approximate distance that was reported from the site.
Patient Sequence No: 1, Text Type: D, B5
[20452177]
Investigation is still in process; therefore, no conclusion can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2007-00015 |
| MDR Report Key | 846456 |
| Report Source | 01,05,06 |
| Date Received | 2007-05-07 |
| Date of Report | 2007-04-16 |
| Date of Event | 2007-04-14 |
| Date Mfgr Received | 2007-04-16 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2007-05-15 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 550 TXT TREATMENT TABLE |
| Generic Name | COUCH, RADIATION, THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2007-05-07 |
| Model Number | 07346534 |
| ID Number | 3845 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 833873 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-07 |