DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST 5803

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-12-22 for DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST 5803 manufactured by Orthopedic Systems, Inc..

Event Text Entries

[18513340] The pt was undergoing hip arthroplasty, and after the distraction of the right hip joint was applied, an attempt was made to tilt the table for better access. The anesthesiologits was unfamiliar with the bed and did not know it would not rotate 180 degrees. She was unable to get the bed to tilt using the hand control and seeing the "lock/unlock" lever on the bed, she unlocked it thinking that was why the bed would not tilt. The tabletop rotated and the pt was left dangling by the two safety straps (across chest and unaffected leg). The healthcare team reacted swiftyly and was able to maintain the security of his airway and reorient the bed. He was moved to another bed.
Patient Sequence No: 1, Text Type: D, B5


[18718504] Device was repaired. User allowed maintenance of table to go beyond safe use. Repair order created, items for repair identified replacement actuator and knob replacement assembly. Table is currently in use.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2921578-2006-00005
MDR Report Key800552
Report Source00
Date Received2006-12-22
Date of Report2006-12-22
Date of Event2006-10-20
Date Mfgr Received2006-12-07
Device Manufacturer Date2004-06-01
Date Added to Maude2007-01-08
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 FDA3
Event Location0
Manufacturer ContactKIRKE JAYNE
Manufacturer Street30031 AHERN AVE
Manufacturer CityUNION CITY CA 945871234
Manufacturer CountryUS
Manufacturer Postal945871234
Manufacturer Phone5104768128
Manufacturer G1*
Manufacturer Street30031 AHERN AVE
Manufacturer CityUNION CITY CA 94587123
Manufacturer CountryUS
Manufacturer Postal Code94587 1234
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST
Generic NameOPERATING ROOM TABLE
Product CodeBWN
Date Received2006-12-22
Model Number5803
Catalog Number5803
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key788090
ManufacturerORTHOPEDIC SYSTEMS, INC.
Manufacturer Address30031 AHERN AVE UNION CITY CA 945871234 US
Baseline Brand NameDEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST
Baseline Generic NameOPERATING ROOM TABLE
Baseline Model No5803
Baseline Catalog No5803
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-12-22

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