inforMED
MalfunctionNDQ

NIOBE MNS PHILIPS

Received Jul 13, 2020 · Event occurred Jun 1, 2020

Report 3003084417-2020-00218 · MDR key 10268322

Device

Generic name

Niobe Es

Manufacturer

Stereotaxis

Model number

ES PHILIPS

Catalog number

001-006100-1

Lot number

N/A

Product problems

  • Self-Activation or Keying
  • Noise, Audible
  • Unexpected Shutdown

Patient

Not reported

  • No Code Available
  • No Code Available

Narrative

Description of Event or Problem

A PATIENT OF UNKNOWN AGE AND GENDER WAS UNDERGOING A VT ABLATION. THE PHYSICIAN HAD ALREADY MAPPED THE LV AND WAS ABLATING THE VENTRICLE. IN THE MIDDLE OF THE PROCEDURE THE PHYSICIAN WAS APPLYING A FIELD THERE WAS A LOUD NOISE THAT SEEMED TO COME FROM MP1 AND THEN THE SYSTEM SHUT OFF ON ITS OWN. TROUBLESHOOTING OCCURRED IMMEDIATELY AT THE SITE, AND THE SYSTEM REMAINED DOWN. AFTER A SHORT PERIOD OF TIME OF TRYING TO BRING THE SYSTEM BACK UP, IT WAS RECOMMENDED THAT THEY HAND CRANK THE MAGNETS AND GO TO A MANUAL APPROACH TO COMPLETE THE ABLATION. TOTAL DELAY TIME WAS APPROXIMATELY 45 MINUTES. TO AVOID REMAPPING OF THE LEFT VENTRICLE, THE PHYSICIAN COMPLETED THE ABLATION MANUALLY AND THE PATIENT REMAINED ON THE TABLE AND THE MAGNETS WERE MOVED TO STOW POSITION. THERE WAS NO INJURY TO THE PATIENT. THERE WAS HOWEVER, SIGNIFICANT DELAY OF THE PROCEDURE.