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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE
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IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE Back to Search Results
Model Number ORT100
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2017
Event Type  malfunction  
Manufacturer Narrative
The service engineer observed that the table roll cylinder was leaking.He removed and replaced the roll cylinder and tested the table to verify proper function.Internal capa issued.
 
Event Description
The ort100 table was found to be exhibiting lateral roll cylinder drift.Surgeons continued to use the table during this time because the drift was so slow that it did not present a safety risk to the patients.
 
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Brand Name
IMRIS ORT100 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 Key7243081
MDR Text Key99198002
Report Number3010326005-2018-00005
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeCH
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 Inspection
Type of Report Initial
Report Date 02/05/2018
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 Physician
Device Model NumberORT100
Device Catalogue Number110470-600
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 08/07/2017
Initial Date FDA Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2010
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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