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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS T2X OR TABLE V2 (ORT100); OPERATING ROOM TABLE
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IMRIS - DEERFIELD IMAGING, INC. IMRIS T2X OR TABLE V2 (ORT100); OPERATING ROOM TABLE Back to Search Results
Model Number ORT100
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
The hydraulic fluid leak was traced to the o-ring gasket between the hydraulic fluid reservoir and the hydraulic pump.The gasket had degraded over time and required replacement.
 
Event Description
On (b)(6) 2022, during preventive maintenance an imris customer service eningineer observed a small leak of hydraulic fluid in the wall mounted control panel of the t2x operating room table.There was no patient involvement and the table passed functional testing during the preventive maintenance service.
 
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Brand Name
IMRIS T2X OR TABLE V2 (ORT100)
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
paul campbell
5101 shady oak road
minnetonka, MN 55343-4100
7632036344
MDR Report Key14805692
MDR Text Key296235780
Report Number3010326005-2022-00010
Device Sequence Number1
Product Code KXJ
UDI-Device Identifier00857534006332
UDI-Public(01)00857534006332
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberORT100
Device Catalogue Number110470-000
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2012
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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