FDA Adverse Event
Malfunction
Summary report: N
MILLENIUM VG DUAL COLLIMATOR
MDR report key: 692347
·
Received March 24, 2006
Report
- Report Number
- 9613299-2006-00005
- Event Type
- Malfunction
- Date Received
- March 24, 2006
- Date of Event
- February 22, 2006
- Report Date
- March 24, 2006
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product Code
- IYX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT'S WEIGHT IS UNK.
Description of Event or Problem · 1
A VG GAMMA CAMERA COLLIMATOR (VPC-45) PARTIALLY RELEASED FROM THE DETECTOR HEAD. THE USER COMPLETED THREE "LIVER" SCAN PROTOCOLS ON THE PT USING THREE ANGLES. IN ORDER TO PERFORM AN ADDITIONAL SPECT SCAN, THE USER BEGAN TO ROTATE AND ALIGN THE DETECTOR HEADS IN THE 0 AND 180 DEGREE POSITIONS, AND NOTICED THAT THE COLLIMATOR WAS PARTIALLY DETECHED FROM THE FRONT TWO LOCKING MECHANISMS. THE USER ROTATED THE GANTRY TO A SAFE POSITION AND RETRACTED THE PT TABLE OUT FROM UNDER DETECTORS. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENIUM VG DUAL COLLIMATOR | NUCLEAR MEDICINE | IYX | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |