FDA Adverse Event
Malfunction
Summary report: N
LINEAR SERIES COLLIMATORS
MDR report key: 314486
·
Received January 29, 2001
Report
- Report Number
- 1423380-2001-00001
- Event Type
- Malfunction
- Date Received
- January 29, 2001
- Report Date
- January 25, 2001
- Manufacturer
- PROGENY, INC.
- Product Code
- KPW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
CERTAIN BATCHES OF COLLIMATORS BUILT IN SEP-OCT 1999 HAVE INCORRECT (SHORTER) SCREWS MOUNTING THE COLLIMATOR HOUSING TO THE TUBE MOUNTING PLATE. THE SHORTER SCREWS OVER TIME CAN LOOSEN, ALLOWING THE COLLIMATOR HOUSING TO SAG RELATIVE TO THE MOUNTING PLATE. IF THE "LOOSENESS" OF THE HOUSING WAS NOT NOTICED BY STAFF, THE HOUSING COULD EVENTUALLY SEPARATE FROM THE MOUNTING PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3433 | LINEAR SERIES COLLIMATORS | COLLIMATOR | KPW | PROGENY, INC. | LINEAR MC150, LINEAR II, LINEAR III, LINEAR IV | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |