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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 Problems Controller; Fluid Leak; Mechanical Problem; Hydraulic System
Event Date 08/09/2018
Event Type  Malfunction  
Manufacturer Narrative

The ort100 table has not yet been evaluated. A follow-up report will be submitted once root cause has been established.

 
Event Description

The customer stated that the ort100 table stopped moving during daily testing. They observed hydraulic fluid in the control panel of the table. There was no patient involvement.

 
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Brand NameIMRIS ORT100 OPERATING ROOM TABLE
Type of DeviceOPERATING ROOM TABLE
Manufacturer (Section D)
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 Key7854812
Report Number3010326005-2018-00037
Device Sequence Number1
Product CodeKXJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/07/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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