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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. ORT300 OPERATING ROOM TABLE

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IMRIS-DEERFIELD IMAGING, INC. ORT300 OPERATING ROOM TABLE Back to Search Results
Model Number ORT300
Device Problems Fluid Leak (1250); Leak/Splash (1354); Loose or Intermittent Connection (1371); Table (3117)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
Event Type  Malfunction  
Manufacturer Narrative

The service engineer observed that the hydraulic line of the or table had ruptured. He replaced the ruptured pipe and tested the table to verify proper function.

 
Event Description

The customer stated they observed that the ort300 table was leaking hydraulic fluid. There was no patient involvement.

 
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Brand NameORT300 OPERATING ROOM TABLE
Type of DeviceOPERATING 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 Key7281109
MDR Text Key100558876
Report Number3010326005-2018-00022
Device Sequence Number1
Product Code KXJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberORT300
Device Catalogue Number114093-000
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/18/2016
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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