MalfunctionKDP
AMVEX
Received Jul 16, 2009
Report 9617620-2009-01004 · MDR key 1488180
Device
Product problems
- Nonstandard Device
- Failure to Shut Off
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B) (4): THE UNIT WILL NOT SHUT OFF AT "ZERO" POSITION. THE COMPLAINT DID NOT REPORT THAT THERE WAS ANY ADVERSE CONSEQUENCES FOR PTS.
Additional Manufacturer Narrative
THE FLOWMETERS LEAKED AT "CLOSED" POSITION DUE TO MANUFACTURE ASSEMBLY ERROR. AMVEX HAS INITIATED A RECALL THE SUSPECTED UNITS.
Remedial action
- Recall