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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
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IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE Back to Search Results
Model Number ORT100 (T2)
Device Problems Fluid/Blood Leak (1250); Device Maintenance Issue (1379); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
The service engineer indicated that there was a negligible amount of hydraulic fluid at the back tilt cylinder fitting.A service call is scheduled to repair the fitting.Internal capa issued.
 
Event Description
During routine preventive maintenance, the customer service engineer observed a small amount of hydraulic fluid at the back tilt cylinder fitting on the operating room table.No patient involvement.
 
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Brand Name
IMRIS ORT300 OPERATING ROOM TABLE
Type of Device
OPERATING ROOM 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 Key7251855
MDR Text Key99810527
Report Number3010326005-2018-00020
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Remedial Action Inspection
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberORT100 (T2)
Device Catalogue Number108000-000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2006
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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