MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-10 for ECAM 5242826 * manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[605814]
A patient had a bone scan. The customer states that the patient attempted to get off the patient bed after the completion of the scan, unassisted by the technologist. The patient tried to hold the sides to get off. During this process, somehow his fingers went underneath the field-of-view indicators, he used his weight to pull himself up and tried to remove his fingers while his own weight was pressing the field-of-view indicators down, causing the injury. The physician at the clinic has reported that the patient informed him that follow up care required partial amputation at the finger tip to repair skin damage. "
Patient Sequence No: 1, Text Type: D, B5
[7962402]
No device failure. Based on customer feedback, the patient attempted to get off the patient bed unassisted. Cautions/labeling ignored. Labels in place and in good condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2007-00002 |
| MDR Report Key | 836804 |
| Report Source | 05,07 |
| Date Received | 2007-04-10 |
| Date of Report | 2007-03-15 |
| Date of Event | 2007-03-14 |
| Date Mfgr Received | 2007-03-15 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2007-04-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARIA EBIO |
| Manufacturer Street | 810 INNOVATION DRIVE |
| Manufacturer City | KNOXVILLE TX 37932 |
| Manufacturer Country | US |
| Manufacturer Postal | 37932 |
| Manufacturer Phone | 8652182534 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECAM |
| Generic Name | GAMA CAMERA |
| Product Code | IYX |
| Date Received | 2007-04-10 |
| Model Number | 5242826 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 824100 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP |
| Manufacturer Address | * HOFFMAN ESTATES IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-10 |