OT1200 TABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-20 for OT1200 TABLE manufactured by Steris Corporation - Montgomery.

Event Text Entries

[3981391] The user facility reported that during a procedure an ot1200 surgical table was not operating properly. No injuries were reported. No procedural delays or cancellations occurred.
Patient Sequence No: 1, Text Type: D, B5


[11387376] Investigation remains in process; a follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1043572-2013-00137
MDR Report Key3531216
Report Source06
Date Received2013-12-20
Date of Report2013-12-20
Date of Event2013-11-20
Date Mfgr Received2013-11-20
Date Added to Maude2014-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS KATHRYN CADORETTE
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927231
Manufacturer G1STERIS CORPORATION - MONTGOMERY
Manufacturer Street2720 GUNTER PARK DRIVE EAST
Manufacturer CityMONTGOMERY AL 36109
Manufacturer CountryUS
Manufacturer Postal Code36109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOT1200 TABLE
Generic NameSURGICAL TABLE
Product CodeJEB
Date Received2013-12-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION - MONTGOMERY
Manufacturer Address2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-20

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