MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-09 for SYMBIA T, T2, T6, T16 08717733 manufactured by Siemens Medical Solutions Usa Inc. Mi Group.
[2075033]
A product problem was discovered during internal release testing. The radiation therapy pallet is wider than the normal pallet and flat. With a small patient, on the pallet and the camera contouring around the legs (the thinnest part of the patient), the light rails may not detect the patient due to the angle at which the detector comes around the edge of the pallet. In this case, the product behavior is as if there was no patient on the pallet at all. In this case, an injury may occur if the detector makes contact with a patient on this pallet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2011-00001 |
| MDR Report Key | 2143700 |
| Report Source | 07 |
| Date Received | 2011-05-09 |
| Date of Report | 2011-05-24 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2012-04-02 |
| 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 | MARIA EBIO, MANAGER |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8652182534 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1423253-05/27/2011-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIA T, T2, T6, T16 |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2011-05-09 |
| Model Number | 08717733 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA INC. MI GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-09 |