inforMED
MalfunctionFFX

OHMEGA

Received Apr 10, 2019 · Event occurred Feb 22, 2019

Report 8499612 · MDR key 8499612

Device

Generic name

System, Gastrointestinal Motility (electrical)

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.