HUT EXT DR FINAL ASSY-REVERSE 404007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-06 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..

Event Text Entries

[2502733] On (b)(6): customer reports urology table movement hand and foot control not working. On (b)(6): customer reports via e-mail; pt gender and age (b)(6) female. Pt had to be transported from cysto room to another room to complete procedure. Pt was having esophageal retrograde cholangio pancreatography (ercp) by dr. (b)(6). We were able to perform the procedure successfully after changing rooms. No reported injury.
Patient Sequence No: 1, Text Type: D, B5


[9578695] Field service engineer (fse) troubleshot customer complaint of no table movement and found the hydradjust dr table hand control to be bad causing loss of table movement. Fse replaced the handswitch per hut service manual and checked for proper operation by completing hydradjust dr service checklist. Unit passed checkout procedures and ws returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1518293-2011-00239
MDR Report Key2373669
Report Source05,06,07
Date Received2011-12-06
Date of Report2011-12-07
Date of Event2011-11-18
Date Mfgr Received2011-11-18
Device Manufacturer Date2008-02-01
Date Added to Maude2012-04-06
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 ContactDAVID BENSON
Manufacturer Street2111 E. GALBRAITH ROAD
Manufacturer CityCINCINNATI OH 45237
Manufacturer CountryUS
Manufacturer Postal45237
Manufacturer Phone5139485719
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUT EXT DR FINAL ASSY-REVERSE
Generic NameUROLOGY SUITE
Product CodeKQS
Date Received2011-12-06
Model NumberHUT EXT DR
Catalog Number404007
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM CO.
Manufacturer Address2111 E. GALBRAITH RD. CINCINNATI OH 45237 US 45237


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-06

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