BIOMEDIX
Received Jan 31, 2007
Report MW4004280 · MDR key 811227
Device
Product problems
- False Reading From Device Non-Compliance
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
COMPLAINANT WILL SEND E-MAIL WITH SPECIFICS. MULTIPLE PROBLEMS WITH DEVICE. HAS BEEN SENT BACK MULTIPLE TIMES WITHOUT RESOLUTION. LOANER MACHINE DID NOT WORK PROPERLY EITHER. ERRATIC READINGS AND SERIOUS INACCURACIES IN READINGS. EX: MACHINE WILL SAY BLOCKAGE IN LEFT LEG WHEN BLOCKAGE IS ACTUALLY IN RIGHT LEG. LUCKILY EXPERIENCED VASCULAR TECH NOTICED INACCURACIES BEFORE SURGERIES. HAVE HEARD OTHERS IN THE FIELD WITH SAME COMPLAINTS.