SKYTRON 6001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-13 for SKYTRON 6001 manufactured by Skytron.

Event Text Entries

[828974] Operating room table malfunction resulting in pt injury requiring hospitalization and legal claim against facility. Table evaluated by contracted third party repair. Notes indicated user error. Hand control replaced. Table returned to service per contractor's evaluation. Several calls made to third party contractor for complaints of table instability. No faults or table errors found per field service reports. Table returned to service each time with no errors found per field service reports. On 11/15/2006 table malfunctioned with failure of the hydraulic system while a 340+ pound pt was anesthetized on that table. Failure of the hydraulics caused the pt to immediately begin heading head first to the floor. I caught the pt and sustained a personal cervical neck injury which required surgical repair. Table evaluated by third party contractors. Field service report indicated user error. Table returned to service per field service report. In 2007: the same operating room table malfunctioned and locked itself in the full table up, table tilt and leg down position overnight and on its own. Third party contractor notified. Per field service report recommendation: remove table from service due to permanent malfunction and non-repairable state for the safety of future pts. In their own opinion, the table did in fact have underlying issues all along yet because of the transient nature of the problems, it was difficult for them to diagnose.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5005868
MDR Report Key1013899
Date Received2008-03-13
Date of Report2008-03-13
Date of Event2004-11-17
Date Added to Maude2008-03-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSKYTRON 6001
Generic NameOPERATING ROOM TABLE- HYDRAULIC
Product CodeBWN
Date Received2008-03-13
Model Number6001
OperatorHEALTH PROFESSIONAL
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key981567
ManufacturerSKYTRON
Manufacturer AddressGRAND RAPIDS MI US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Deathisabilit 2008-03-13

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