FDA Adverse Event
Malfunction
Summary report: N
SDT-XL
MDR report key: 38601
·
Received September 5, 1996
Report
- Report Number
- 1528274-1996-00014
- Event Type
- Malfunction
- Date Received
- September 5, 1996
- Date of Event
- August 21, 1996
- Report Date
- August 22, 1996
- Manufacturer
- SMV INTL.
- Product Code
- IYX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FIELD SVC ENGINEER WAS CHANGING THE COLLIMATOR. WHEN PUTTING IT IN THE COLLIMATOR STAND IT RELEASED FROM THE CART AND FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SDT-XL | GAMMA CAMERA | IYX | SMV INTL. | DST-XL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |