ERGOSTYLE FX WITH MANUAL DROPS 5820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-30 for ERGOSTYLE FX WITH MANUAL DROPS 5820 manufactured by Chattanooga Group.

Event Text Entries

[19958520] The clinician was lowering the table surface with the patient on the table surface when the motor malfunctioned. The table reached full retraction and the motor continued to attempting to lower the table surface. This action caused the upper yoke where the motor is secured to flex. The flex motion broke the casting of the actuator. The broken piece of casting did eject from under the table.
Patient Sequence No: 1, Text Type: D, B5


[20099810] Awaiting device return and evaluation. Once the device is returned and evaluated, a concluding form 3500a will be sent to the fda-mdr.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1022819-2009-00021
MDR Report Key1343363
Report Source05
Date Received2009-01-30
Date of Report2009-01-06
Date Mfgr Received2009-01-06
Date Added to Maude2009-08-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMICHAEL TREAS
Manufacturer Street4717 ADAMS RD.
Manufacturer CityHIXSON TN 37343
Manufacturer CountryUS
Manufacturer Postal37343
Manufacturer Phone4238702281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameERGOSTYLE FX WITH MANUAL DROPS
Product CodeINW
Date Received2009-01-30
Returned To Mfg2009-01-28
Model Number5820
Catalog Number5820
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP
Manufacturer AddressHIXSON TN US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-01-30

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