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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. IMRIS ORT200 OPERATING ROOM TABLE
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IMRIS-DEERFIELD IMAGING, INC. IMRIS ORT200 OPERATING ROOM TABLE Back to Search Results
Model Number ORT200
Device Problems Unintended System Motion (1430); Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
Event Type  malfunction  
Manufacturer Narrative
The drift in the table was traced to the trend dual counterbalance valve.The valve was replaced and the table was retested to verify proper function.The valve was not returned to the manufacturer.
 
Event Description
Operating room staff noticed that over the weekend and long holiday, the ort200 table had drifted head upwards.There was no patient involved.
 
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Brand Name
IMRIS ORT200 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 Key11195368
MDR Text Key228845686
Report Number3010326005-2021-00001
Device Sequence Number1
Product Code KXJ
UDI-Device Identifier00857534006738
UDI-Public010085753400673811141030
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 Administrator/Supervisor
Remedial Action Replace
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORT200
Device Catalogue Number113821-600
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2014
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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