MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-22 for SYMBIA T6 10275009 manufactured by Siemens Medical Solutions Usa Inc., Mi Group.
[2246403]
An equipment operator injured her finger (broken bone that was immobilized for recovery). The operator was changing the collimator on a nuclear medicine gamma camera. During this incident, the collimator did not line up correctly and the installation of the collimator did not complete. At this time, a message is presented to the operator that provides a close drawer icon and a cancel option. Pressing cancel allows the user to close the drawer and retry or exit collimator change and call service. Our investigation determined that the operator tried to manually move the collimator for 43 minutes. The operator's finger was beneath the collimator. The collimator did then move suddenly and the operator's finger was caught between the collimator and collimator flange, causing injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2011-00002 |
| MDR Report Key | 2226957 |
| Report Source | 07 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-07-20 |
| Date Mfgr Received | 2011-07-20 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2011-09-02 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIA T6 |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2011-08-22 |
| Model Number | 10275009 |
| 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 | 2011-08-22 |