MalfunctionFFX
OHMEGA
Received Apr 10, 2019 · Event occurred Feb 22, 2019
Report 8499612 · MDR key 8499612
Device
Generic name
System, Gastrointestinal Motility (electrical)
Manufacturer
Medical Measurement Systems B.v.Product problems
- Device Alarm System
- Date/Time-Related Software Problem
Patient
21170 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT SENT HOME WITH OHMEGA PH CATHETER AND RECORDER. PATIENT HAD CALLED IN THE EVENING, STATING THE DEVICE WAS NOT SHOWING THE TIME, BUT STATING STILL REGISTERING "RECORD". INSTRUCTED TO UTILIZE AS DIRECTED. UPON RETURN THE NEXT DAY, WHEN RECORDER DOWNLOADED TO MMS, INFORMATION WAS NOT ABLE TO BE DOWNLOADED. ERROR MESSAGE WAS MEMORY FAILURE. MMS MANUFACTURER WAS CALLED. WE ARE STILL WAITING TO HEAR FROM THE MANUFACTURER AS TO WHETHER THE INFORMATION CAN BE RETRIEVED OR THE STUDY WILL NEED TO BE REPEATED FOR THE PATIENT.