MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-10 for SYMBIA S 8717741 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[18579018]
The operator was performing a nuclear medicine study acquisition (scan) of the lungs via spect imaging. The operator would position the patient and move away from the system after initiating the scan/ during this scan, the patient repeatedly (9 times as verified by verbal discussion with the operator and through review of customer system logs) moved her arms, which triggered the patient detect on the detector. After the last such patient movement and interruption, the operator re-positioned the patient and resumed the scan once again. This time, the patient moved her arms and placed her arm behind her head and in the path of the moving detector (backside of the detector). The patient's arm was broken by the moving detector (patient had moved arm into the path of the moving detector).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2009-00002 |
| MDR Report Key | 1413439 |
| Report Source | 05 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-06-27 |
| Date of Event | 2009-06-27 |
| Date Mfgr Received | 2009-06-27 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2009-07-17 |
| 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 NORTH 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 | 2009-07-10 |
| 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 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-10 |