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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 (T2)
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
The service engineer was unable to completely resolve the drift issue in the table.The table is being replaced.
 
Event Description
The customer stated that the or table rolled right two days in a row during patient procedures.There were no injuries reported.
 
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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 Key7297554
MDR Text Key101155103
Report Number3010326005-2018-00027
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberORT100 (T2)
Device Catalogue Number105048-000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
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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