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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE
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DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE Back to Search Results
Model Number ORT100
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  malfunction  
Manufacturer Narrative
The hydraulic pressure hose was replaced and functionality of the table was restored.The cause of the leak in the hose is undeterminable.
 
Event Description
The pressure hose inside the ort100 table was leaking.There was no patient involvement.
 
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Brand Name
IMRIS ORT100 OPERATING ROOM TABLE
Type of Device
OPERATING ROOM TABLE
Manufacturer (Section D)
DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer (Section G)
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 Key8075658
MDR Text Key128399616
Report Number3010326005-2018-00040
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeQA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORT100
Device Catalogue Number110470-000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2012
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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