SERVO SERVO I MR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-29 for SERVO SERVO I MR * manufactured by Maquet Critical Care Ab.

Event Text Entries

[3717314] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3364129
• MDR Report Key: 3364129
• Date Received: 2013-08-29
• Date of Report: 2013-08-29
• Date of Event: 2013-04-05
• Report Date: 2013-08-29
• Date Reported to FDA: 2013-08-29
• Date Reported to Mfgr: 2013-09-24
• Date Added to Maude: 2013-09-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SERVO
• Generic Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Product Code: CBK
• Date Received: 2013-08-29
• Model Number: SERVO I MR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 5 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAQUET CRITICAL CARE AB
• Manufacturer Address: 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470

Device Sequence Number: 2

• Brand Name: SIEMENS
• Generic Name: COIL, MAGNETIC RESONANCE, SPECIALTY
• Product Code: MOS
• Date Received: 2013-08-29
• Model Number: SKYRA 3T
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DAY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MAQUET CRITICAL CARE AB
• Manufacturer Address: 45 BARBOUR POND DRIVE WAYNE PA 07470 US 07470

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-08-29