MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-30 for GE NUCLEAR MEDICINE CAMERA ASM001301 * manufactured by Ge Medical Systems, Llc.
[17767939]
While doing a parathyroid study, the ge camera safety sensor failed to work. The camera head came down too close to the patient and pressed on her arm and chest for two or three seconds. The hand held controller was also not working properly. There was no patient injury due to the malfunction of the safety sensor. The camera was taken out of service and a ge service technician was called to repair the equipment. A copy of the ge service report is not available. The camera was returned to service after the repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 838369 |
| MDR Report Key | 838369 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-03-30 |
| Date of Event | 2006-12-07 |
| Report Date | 2007-03-30 |
| Date Reported to FDA | 2007-03-30 |
| Date Added to Maude | 2007-04-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE NUCLEAR MEDICINE CAMERA |
| Generic Name | CAMERA, NUCLEAR MEDICINE |
| Product Code | IYX |
| Date Received | 2007-03-30 |
| Model Number | ASM001301 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825673 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 NORTH GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-30 |