MEDISYSTEMS
Received Jul 6, 2004
Report MW1032560 · MDR key 540713
Device
Generic name
Transducer Protector
Manufacturer
MedisystemsModel number
K3-9642/9795Catalog number
K3-9642/9795
Lot number
UNABLE TO DETERMINE
Product problems
- Leak/Splash
- Replace
Patient
*
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
AN INTERNAL TRANDSUCER PROTECTOR ON A FRESENIUS 2008E MACHINE WAS FOUND TO HAVE A SMALL AMOUNT OF BLOOD IN IT. REPORTER IMMEDIATELY CHANGED THE INTERNAL TRANSDUCER PROTECTOR. THERE IS NO WAY TO DETERMINE HOW LONG THE PROBLEM EXISTED OR THE LOT NUMBER OF THE EXTERNAL TRANSDUCER PROTECTORS USED.