SUINSA (MARKETED BY CARESTREAM) NOVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-28 for SUINSA (MARKETED BY CARESTREAM) NOVA manufactured by Suinsa.

Event Text Entries

[1175833] The technician was positioning the otc (overhead tube crane) over a patient on the table for a lateral exam. The technician pressed the "alpha" button, also inadvertently pressing the? All? Button on the otc operator handle. The otc motor drove the otc vertically downward at a higher than usual rate of speed. The operator did not release the "all" button quickly enough to prevent patient contact. The otc contacted the patient with some amount of force in the hip area. The patient saw a physician in 2009. No injury was diagnosed.
Patient Sequence No: 1, Text Type: D, B5


[8312864] The strain gauge signal will be evaluated prior to vertical servo motor assistance is connected/enabled. Strain gauge signal will be now measured by a new revision of the board that monitors the activation/deactivation of the otc (overhead tube crane) handle buttons. At the moment that any dead man button that demands vertical assisted movement is enabled by operator ("all" or "vertical") if the strain gauge effort readout is not 0 (or close to, due to tolerance band) such board will ignore such button demand. Therefore, if strain gauge malfunction occurs (like incident described), whenever operator tries to move otc vertical axis by depressing button, the new revision board will detect a non close to 0 effort and therefore such button depress will be completely ignored, and the motor servo assistance will not be connected at all.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1000404222-2009-00001
MDR Report Key1484401
Report Source05,06
Date Received2009-09-28
Date of Report2009-09-09
Date of Event2009-08-11
Date Mfgr Received2009-09-02
Device Manufacturer Date2008-08-08
Date Added to Maude2009-10-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRADIOLOGIC TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. RANDY DUFFY
Manufacturer Street2920 N. ARLINGTON HEIGHTS RD
Manufacturer CityARLINGTON HEIGHTS IL 60004
Manufacturer CountryUS
Manufacturer Postal60004
Manufacturer Phone8473946960
Manufacturer G1SUINSA
Manufacturer StreetC/PRIMAVERA, 39 TORREJ
Manufacturer CityMADRID, 28850
Manufacturer CountrySP
Manufacturer Postal Code28850
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUINSA (MARKETED BY CARESTREAM)
Generic NameTUBE MOUNT, X-RAY, DIAGNOSTIC
Product CodeIYB
Date Received2009-09-28
Model NumberNOVA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSUINSA
Manufacturer AddressC/. PRIMAVERA, 39 PARQUE IND LAS MOJAS TORREJON DE ARDOZ MADRID, 28850 SP 28850


Patients

Patient NumberTreatmentOutcomeDate
10 2009-09-28

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