MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-30 for MILLENNIUM MC * manufactured by Ge Medical Systems, Llc.
[627268]
Patient was "stuck" under the machine for 30 minutes and the nuclear medicine tech was unable to get the table to retract. The tech finally manually slid the patient out after detaching the table pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 853375 |
| MDR Report Key | 853375 |
| Date Received | 2007-04-30 |
| Date of Report | 2007-04-30 |
| Date of Event | 2007-02-19 |
| Report Date | 2007-04-30 |
| Date Reported to FDA | 2007-04-30 |
| Date Added to Maude | 2007-05-22 |
| 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 | MILLENNIUM MC |
| Generic Name | GAMMA CAMERA SYSTEM, TABLE |
| Product Code | IYX |
| Date Received | 2007-04-30 |
| Model Number | MILLENNIUM MC |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 839257 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 NORTH GRANDVIEW BLVD WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-30 |