MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-31 for ROBOCOUCH PATIENT SUPPORT SYSTEM NA manufactured by Accuray, Incorporated.
[1135741]
During patient setup prior to treatment, a site reported that the robocouch patient support system's table top unexpectedly descended several inches; the patient was removed from the system by the attending medical staff prior to further descent of the table top. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8309618]
The cause was traced to a manufacturing defect of the pulley/motor assembly. Field service engineering corrected the error resolving the issue. All robocouch systems will be inspected by field service engineering.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950679-2009-00005 |
| MDR Report Key | 1470309 |
| Report Source | 05 |
| Date Received | 2009-07-31 |
| Date of Report | 2009-07-31 |
| Date of Event | 2009-07-03 |
| Date Mfgr Received | 2009-07-06 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2009-12-01 |
| 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 | JOY SACMAR |
| Manufacturer Street | 1310 CHESAPEAKE TERRACE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4087164651 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROBOCOUCH PATIENT SUPPORT SYSTEM |
| Generic Name | ROBOCOUCH SYSTEM |
| Product Code | JAI |
| Date Received | 2009-07-31 |
| Model Number | ROBOCOUCH |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCURAY, INCORPORATED |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-31 |