MAUDE Adverse Event Report: MAQUET CRITICAL CARE MAQUET SERVO-I VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number SERVO I

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 02/27/2014

Event Type  No Answer Provided  

Event Description

Imaging staff members were setting up to do a mri scan of an icu patient and the respiratory therapist went into the magnet room with the mri conditional ventilator (claiming he had done it before and knew what he was doing) and brought the ventilator too close; therefore it was sucked to the side of the mri machine.Staff members were able to pull off the ventilator and the batteries.

• Brand Name: MAQUET SERVO-I VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 3657327
• MDR Text Key: 4281780
• Report Number: 3657327
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Health Professional
• Device Model Number: SERVO I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2014
• Patient Sequence Number: 1