MalfunctionFEN
ETHICON GYNECARE
Received Jul 30, 2009 · Event occurred Jul 17, 2009
Report MW5012114 · MDR key 1429323
Device
Generic name
Uro Dynamic Measurement Device
Manufacturer
EthiconCatalog number
URP2103
Lot number
AVL09U002
Product problems
- Failure to Read Input Signal
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHEN OB-GYN PHYSICIAN ATTEMPTED TO PERFORM A BLADDER STUDY ON A PT IN PHYSICIAN'S OFFICE, ETHICON GYNECARE MONITOR WAS CONNECTED TO COMPUTER AND DID NOT REGISTER. DEVICE WAS REPLACED WITH NO ADVERSE OUTCOME TO PT.