MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-05-20 for SYMBIA T2 10275008 manufactured by Siemens Medical Solutions Usa, Inc..
[4503045]
A pt presented for a nuclear medicine scan with a preexisting condition; paralysis of the right arm. The pt was positioned for a brain scan. During the scan, the pt's right arm/hand moved into the path of the moving system parts. The hand/arm was caught during the movement and the radial bone in the right arm during the movement and the radial bone in the right arm was broken. There was no device failure or malfunction. The product labeling adequately instructs the users to monitor patients at all time while in motion to avoid any risk of injury. The product labeling adequately describes positioning the pt and that before system movement, the user must verify that the pt or people in the area are clear of contact, and that the system can travel without its movements being obstructed. The labeling adequately describes that the user may consider using armrest accessories to assist with arm positioning to avoid system contact. The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2014-00002 |
| MDR Report Key | 3836228 |
| Report Source | 01,05,07 |
| Date Received | 2014-05-20 |
| Date of Report | 2014-04-28 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-04-28 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2014-05-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA MEYER |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8473046022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIA T2 |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2014-05-20 |
| Model Number | 10275008 |
| 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. |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-20 |