SERVO
Received Aug 29, 2013 · Event occurred Apr 5, 2013
Report 3364129 · MDR key 3364129
Device
Generic name
Ventilator, Continuous, Facility Use
Manufacturer
Maquet Critical Care AbModel number
SERVO I MRCatalog number
*
Lot number
*
Product problems
- Device Operates Differently Than Expected
Patient
*
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE MR-CONDITIONAL VENTILATOR WAS PULLED TO THE FRONT HOUSING OF THE MR SCANNER. IT WAS PHYSICALLY REMOVED WITHOUT QUENCHING THE MAGNET. THIS EVENT OCCURRED DURING TESTING OF THE NEWLY INSTALLED MR SCANNER PRIOR TO THE ROOM OPENING FOR PATIENT CARE. NOBODY WAS INJURED. THE MAQUET VENTILATOR CONTAINS SOME FERROMAGNETIC COMPONENTS INCLUDING UP TO 6 BATTERIES. MAQUET SPECIFIES THAT THE VENTILATOR MAY BE USED IN 3T MRI SCANNERS AS LONG AS IT IS PLACED AT A DISTANCE WHERE THE MAGNETIC FIELD STRENGTH IS 200 GAUSS OR LESS. THE VENTILATOR WAS PLACED IN A LOCATION WHERE THE FIELD STRENGTH WAS LATER MEASURED TO BE OVER 400 GAUSS. ====================== MANUFACTURER RESPONSE FOR VENTILATOR - MR COMPATIBLE, MAQUET (PER SITE REPORTER).====================== MANUFACTURER RESPONSE FOR MRI SCANNER, SIEMENS (PER SITE REPORTER).