FDA Adverse Event Malfunction Summary report: N

MAQUET INC.

MDR report key: 2061292 · Received April 12, 2011

Report

Report Number
MW5020256
Event Type
Malfunction
Date Received
April 12, 2011
Date of Event
March 29, 2011
Report Date
April 12, 2011
Manufacturer
MAQUET, INC.
Product Code
CBK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
DC, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

SITUATION: MRI COMPATIBLE VENTILATOR FROM RT WAS BROUGHT INTO A 3-TESLA MRI SCAN ROOM BY A RESPIRATORY CARE PERSON AND A MRI SAFETY TRAINED NURSE (RNII). AS THEY ENTERED THE ROOM WITH THE VENTILATOR, IT (THE VENTILATOR) WAS DRAWN TO THE MAGNET. BACKGROUND: THIS IS AN MRI CONDITIONAL DEVICE. MRI CONDITIONAL MEANS THAT THE OPERATOR NEEDS TO KNOW THE CONDITIONS IN WHICH THE DEVICE CAN BE USED. THE CONDITIONS THAT THE VENTILATOR CAN BE USED INCLUDE: IT MUST BE KEPT OUTSIDE OF THE 200-GAUSS LINE (AS PERMANENTLY MARKED ON OUR FLOOR). THE DEVICE MUST BE TETHERED TO THE WALL. THE DEVICE'S WHEELS MUST BE LOCKED. AS A CONDITIONAL DEVICE, THE DEVICE SHOULD NOT BE ABLE TO CAUSE SERIOUS INJURY, PERSONAL HARM OR DEATH PER THE MRI CONDITIONAL TAG (YELLOW TRIANGLE WITH BLACK BORDER AND MR WRITTEN IN BLACK INSIDE OF THE TRIANGLE). SPECIFIC TRAINING WAS GIVEN TO (B)(6) IN (B)(6) 2010 ABOUT PROPER USE OF DEVICE(S) IN MRI SCAN ROOM. MR-SAFETY OFFICER HAD PREVIOUSLY TESTED DEVICE BY BRINGING IT CLOSE TO THE 3-TESLA MAGNET AND NO MAGNET PULL WAS DISCOVERED. ANALYSIS: DEVICE HAS BECOME MAGNETIZED OVER TIME. RECOMMENDATIONS: RELABELING OF EXISTING VENTILATORS SHOULD RESULT MR HAZARD WITH TAG THAT WAS WHITE CIRCLE WITH RED BORDER AND RED LINE THROUGH BLACK LETTERS "MR" (LETTERS INSIDE OF THE CIRCLE). MANUFACTURER SHOULD REPLACED COMPONENTS THAT ARE EITHER FERRO-MAGNETIC OR MAGNETIZABLE WITH COMPONENTS THAT WILL NOT PULL IN MAGNETIC FIELD NOR BECOME MAGNETIZED OVER TIME. ALSO SEE (B)(4). DATES OF USE: ((B)(6) 2010 - (B)(6) 2011). DIAGNOSIS OR REASON FOR USE: RESPIRATORY CARE - VENTILATION OF PT - INSIDE OF MRI.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAQUET INC. SERVO I VENTILATOR CBK MAQUET, INC.

Patients

Seq Age Sex Outcome Treatment
1