FDA.reportPublic FDA data

MAUDE MDR 7854812

MDR report key
7854812
Report number
3010326005-2018-00037
Event key
0
Event type
3
Date of event
2018-08-09
Date received
2018-09-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. TODD SPERLING
Address
5101 SHADY OAK ROAD MINNETONKA MN 55343 US
Phone
763-763-7632
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMRIS ORT100 OPERATING ROOM TABLEOPERATING ROOM TABLEDEERFIELD IMAGING, INC.KXJORT100110470-000N/AY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-070

Event Narratives#

N

Patient 1

THE ORT100 TABLE HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ROOT CAUSE HAS BEEN ESTABLISHED.

D

Patient 1

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.