FDA Adverse Event
Injury
Summary report: N
MAXXUS CART
MDR report key: 518109
·
Received March 25, 2004
Report
- Report Number
- 2126677-2004-00006
- Event Type
- Injury
- Date Received
- March 25, 2004
- Date of Event
- February 29, 2004
- Report Date
- March 25, 2004
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- IYX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A HEALTH CARE PROFESSIONAL WAS INJURED WHEN A COLLIMATOR CARTRIDGE FOR A MAXXUS NUCLEAR SYSTEM FELL OFF OF THE COLLIMATOR CART. THE EVENT OCCURRED WHILE THE CART WAS BEING POSITIONED BETWEEN THE SYSTEM'S TWO DETECTORS IN ORDER TO LOAD COLLIMATOR FROM THE CART. THE TECHNICIAN WAS RESTING THEIR HAND ON THE COLLIMATOR RELEASE LEVER WHEN THE COLLIMATOR CARTRIDGE UNEXPECTEDLY SEPARATED FROM THE CART. AS A RESULT THEIR FINGERS WERE CRUSHED BETWEEN THE COLLIMATOR RELEASE LEVER AND THE TOP POST OF THE CART. THE TECHNICIAN SUFFERED TWO BROKEN FINGERS AND LACERATIONS ON THEIR HAND THAT REQUIRED STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXXUS CART | NUCLEAR MEDICINE | IYX | GE MEDICAL SYSTEMS | 45296733 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |