MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-10 for ECAM 7324143 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[19280163]
Customer indicates that an unattended pt, who was sedated on dilaudid rolled off the e. Cam pt bed (pallet). The fall resulted in broken orbit, humerus bones, and broken teeth.
Patient Sequence No: 1, Text Type: D, B5
[19324716]
Our investigation has determined that the pt was sedated on dilaudid and unattended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2008-00001 |
| MDR Report Key | 1198343 |
| Report Source | 05 |
| Date Received | 2008-10-10 |
| Date of Report | 2008-09-11 |
| Date of Event | 2008-09-11 |
| Date Mfgr Received | 2008-09-11 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2008-10-21 |
| 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 | 2008-10-10 |
| Model Number | 7324143 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1243765 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP |
| Manufacturer Address | HOFFMAN ESTATES IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-10 |