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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE; RADIOLOGIC TABLE
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IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE; RADIOLOGIC TABLE Back to Search Results
Model Number ORT300
Device Problems Unintended System Motion (1430); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
The field service engineer investigated this incident on october 27, 2017.He inspected the table and tested it for drift.He was unable to verify the drift symptoms.After he removed the covers of the table, he observed some small hydraulic fluid leakage from the manifold area.This could potentially be the underlying cause of the drift.The field service engineer will be replacing the leaking hydraulic component(s) and performing functional testing to verify proper operation after the repair has been completed.
 
Event Description
The procedure had been successfully performed and mr imaging was completed.Hospital personnel were moving the magnet away from the table when they noticed contact between the head fixation device, which was attached to the table, and the bore of the magnet.This contact was not evident when the magnet was initially moved over the table and they assumed that the table drifted slightly downward.They lifted up on the back section of the table a small amount to eliminate the contact and then continued moving the magnet away from the table.There was no report of patient injury.
 
Manufacturer Narrative
Evaluation of the table in question and corrective actions taken as follows: the customer service field engineer replaced two leaking hydraulic flow control valves and tightened a loose fitting on one of the hydraulic cylinders.The hydraulic fluid was flushed and a new filter installed.The hydraulic system was bled of air.Testing was performed on the table to verify proper function.The table operates within specification.Internal (b)(4) was issued.
 
Event Description
The procedure had been successfully performed and mr imaging was completed.Hospital personnel were moving the magnet away from the table when they noticed contact between the head fixation device, which was attached to the table, and the bore of the magnet.This contact was not evident when the magnet was initially moved over the table and they assumed that the table drifted slightly downward.They lifted up on the back section of the table a small amount to eliminate the contact and then continued moving the magnet away from the table.There was no report of patient injury.
 
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Brand Name
IMRIS ORT300 OPERATING ROOM TABLE
Type of Device
RADIOLOGIC TABLE
Manufacturer (Section D)
IMRIS - DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer (Section G)
IMRIS - DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer Contact
todd sperling
5101 shady oak road
minnetonka, MN 55343-4100
7632036344
MDR Report Key7034961
MDR Text Key93207102
Report Number3010326005-2017-00011
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberORT300
Device Catalogue Number114093-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/12/2017
Initial Date FDA Received11/15/2017
Supplement Dates Manufacturer Received10/12/2017
Supplement Dates FDA Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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