Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. IMRIS T2X OPERATING ROOM TABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMRIS-DEERFIELD IMAGING, INC. IMRIS T2X OPERATING ROOM TABLE Back to Search Results
Model Number T2X
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2019
Event Type  malfunction  
Manufacturer Narrative
The service engineer diagnosed the leak at the o-ring seal between the or table hydraulic pump and hydraulic fluid reservoir.The o-ring exhibited degradation and was removed and replaced.
 
Event Description
The customer stated that the hydraulic pump on the t2x operating room table is exhibiting a leak where the reservoir attaches.There was no patient involved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMRIS T2X 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 Key8681358
MDR Text Key147464744
Report Number3010326005-2019-00010
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeUS
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 Repair
Type of Report Initial
Report Date 06/09/2019
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 Health Professional
Device Model NumberT2X
Device Catalogue Number109682-600
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2019
Initial Date FDA Received06/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-