| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COMPAX 40E | GE MEDICAL SYSTEMS, LLC | IZZ | 45435245 | NA | NA | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-03-19 | 0 | 1. R |
Patient 1
DURING A ROUTINE EXAM, A SITE TECHNOLOGIST WAS POSITIONING THE COLLIMATOR OVER A PATIENT WHEN THE COLLIMATOR FELL AND CONTACTED THE PATIENT'S FACE. ACCORDING TO THE SITE, THE PATIENT REQUIRED 15 STITCHES ON HIS FACE. A CT SCAN WAS PERFORMED ON THE PATIENT, AND FOUND NO SKELETAL DAMAGE.
Patient 1
GE FIELD ENGINEERS (FE) WERE DISPATCHED TO THE SITE AND EVALUATED THE SYSTEM. THE FES FOUND 3 MISSING INTERFACE SCREWS. THE SCREWS WERE THEN INSTALLED. THE FES VERIFIED THAT THE REPORTED CONDITION WAS FIXED. FURTHER INVESTIGATION REVEALED THAT THE SITE IS NOT UNDER A GE SERVICE CONTRACT. GE PERFORMED THE LAST PREVENTATIVE MAINTENANCE 1 YEAR PRIOR TO THE INCIDENT. IN 2008, GE REPLACED THE TUBE. HOWEVER, THERE WAS NO RECORD THAT THE SITE REQUESTED FOR THE 6-MONTH PREVENTATIVE MAINTENANCE SERVICE FROM GE AS REQUIRED AFTER THE REPLACEMENT. ADDITIONALLY, IT WAS REPORTED THAT THE SITE HAD DAMAGED THE COLLIMATOR LATER IN THE YEAR. GE PROVIDED A QUOTE FOR A NEW COLLIMATOR BUT THE SITE DECIDED TO TAPE THE DAMAGED PART. NO FURTHER INFORMATION WAS RECEIVED FROM THE SITE REGARDING HOW THE COLLIMATOR WAS IMPACTED AFTER THEY HAD FIXED THE DAMAGED PART. MULTIPLE ATTEMPTS WERE MADE BY GE TO OBTAIN PATIENT INFORMATION. NO RESPONSE HAS BEEN RECEIVED FROM THE SITE.