Device product
Drager PT 4000 Phototherapy System
Z-1950-2012
Product summary
- Event
- Event 62470
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65
- Official record key
device-enforcement:Z-1950-2012
Official wording
Reason: A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Code information: Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025.
Distribution pattern: Nationwide Distribution-USA (nationwide) and Puerto Rico.
Derived failure modes
-
Unknown
A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b