MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-12-30 for NM MILLENNIUM MPR COLLIMATOR NA manufactured by Ge Medical Systems, F.i. Haifa.
[376628]
A report was received concerning a pt nose injury in mpr system. The event occurred in preparation for thyroid scan with legp collimator. The user lowered the detector head at normal speed, using the hand held controller while pt was lying on bed. Without being noticed by the operator, the detector came in contact to the pt nose. The gantry movement was stopped upon psd activation, but the pt nose was damaged; potentially broken. The scan was stopped and no further scans were made to the pt. System was rechecked by filed engineering for normal spd operation (stop motion upon slight contact by the operator). The system behaved normally and was returned to normal use routines for the same type of scans with other pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613299-2004-00010 |
| MDR Report Key | 563044 |
| Report Source | 05,07 |
| Date Received | 2004-12-30 |
| Date of Report | 2004-12-30 |
| Date of Event | 2004-11-29 |
| Date Mfgr Received | 2004-11-29 |
| Date Added to Maude | 2005-01-05 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY OVERLAND, PH.D. |
| Manufacturer Street | 3000 NORTH GRANDVIEW BLVD W400 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, FI HAIFA |
| Manufacturer Street | 4 HAYOZMA ST. |
| Manufacturer City | TIRAT HACARMEL 30200 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 30200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NM MILLENNIUM MPR COLLIMATOR |
| Generic Name | COLLIMATOR |
| Product Code | IZX |
| Date Received | 2004-12-30 |
| Model Number | NI |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 552769 |
| Manufacturer | GE MEDICAL SYSTEMS, F.I. HAIFA |
| Manufacturer Address | 4 HAYOZMA ST. TIRAT HACARMEL IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-30 |