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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 ORT300
Device Problem Unintended Movement (3026)
Patient Problem No Information (3190)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
The table drift was resolved by replacing the check valve block in the manifold.The table was tested to verify proper function.
 
Event Description
The customer stated that the ort300 table is drifting in the trendelenburg overnight when not in use while unloaded.Observed during daily qa/ inspection.
 
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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 Key7403791
MDR Text Key104887813
Report Number3010326005-2018-00030
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 Inspection
Type of Report Initial
Report Date 04/06/2018
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
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/13/2018
Initial Date FDA Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
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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