OMEGA 2000 MEG SYSTEM
Received Jun 22, 2012 · Event occurred Jun 18, 2012
Report 9616854-2012-00001 · MDR key 2632732
Device
Generic name
Magnetoencephalograph
Product problems
- Self-Activation or Keying
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A USER OF THE DEVICE REPORTED THAT WHILE TRYING TO RAISE THE SUBJECT INTO THE MEG HELMET THE PT SUPPORT (CHAIR) CONTINUED TO RISE OUTSIDE OF THE OPERATOR'S CONTROL, STOPPING ONLY WHEN IT REACHED ITS MAXIMUM HEIGHT AGAINST THE DEWAR. THE USER CONFIRMED THAT THE SUBJECT WAS ABLE TO GET OUT OF THE CHAIR UNINJURED BUT EXPRESSED CONCERN OF POTENTIAL INJURY IF S/HE HAD NOT BEEN ABLE TO OUT BEFORE THE CHAIR GOT TOO HIGH.
Additional Manufacturer Narrative
(B)(4) THE ENTITY REPORTING THIS EVENT, PROVIDES MAINTENANCE SERVICE AND SUPPORT FOR THIS DEVICE. ALTHOUGH NOT THE MFR, (B)(4) HAS MADE AWARE OF THIS EVENT AND HAS SENT AN INITIAL NOTIFICATION TO ALL OTHER KNOWN USERS OF SIMILAR EQUIPMENT. (B)(4) WILL INVESTIGATE AND OFFER TO RECTIFY THE PROBLEM AT OTHER POTENTIALLY AFFECTED EQUIPMENT.
Remedial action
- Notification