MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-19 for SYMBIA S 8717741 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[1392313]
The operator was performing a study acquisition (scan) of the lungs via spect imaging. Review of the system logs and interview of local service engineer indicated that the operator positioned the pt and left the room. Nuclear medicine studies (scans) require the pt to remain still and unmoving during the scan. The unattended pt moved their leg during the scan. The operator alleges that the pt's leg was out (5 cm cut required stitches) by a moving component (pt had moved leg into the path of the moving detector). By leaving the pt unattended, the operator was not present to stop system motion with the e-stop button.
Patient Sequence No: 1, Text Type: D, B5
[8304558]
Results: no device malfunction. Conclusions: investigation on-going.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2009-00003 |
| MDR Report Key | 1541459 |
| Report Source | 05 |
| Date Received | 2009-11-19 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-10-19 |
| Date Mfgr Received | 2009-10-19 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2009-11-23 |
| 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 |
| Manufacturer Street | 2501 N. BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8652182534 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIA S |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2009-11-19 |
| Model Number | 8717741 |
| Operator | HEALTH PROFESSIONAL |
| 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 N. BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-19 |