MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-23 for ECAM 52428261 manufactured by Siemens Medical Solutions Usa, Inc..
[1685596]
A pt was being scanned on the (b)(4) camera system. When the pt was exiting the phs (pt handling system), the operator was assisting the pt on the left side and the pt sat on the fov (field of view) guide with their right finger under the guide. The weight of the pt pressed down on the guide and the pressure fractured the pt's finger.
Patient Sequence No: 1, Text Type: D, B5
[8875818]
Results: this injury occurred on the system before the system rec'd the (b)(4). Update. Conclusions: user error contributed to event in that the operator did not inform the pt about the flip up guides and did not ensure that the pt exited the system safely. The customer system will be updated with (b)(4), which replaces/updates the fov flip up guides.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2010-00005 |
| MDR Report Key | 1938117 |
| Report Source | 06 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-11-23 |
| Date Mfgr Received | 2010-11-23 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2011-01-18 |
| 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 | ECAM |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2010-12-23 |
| Model Number | 52428261 |
| 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 | 2010-12-23 |