TRT-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-12-05 for TRT-200 manufactured by Chattanooga Group, Inc..

Event Text Entries

[15513027] Outpatient sat on physical therapy treatment table when it was in the low position. After she sat/laid down the table began to elevate, and continued to rise. Patient fell off the table, was stabilized and sent to the emergency department where she was treated for a dislocated shoulder and fractured arm due to the fall. Clinical engineering department has sequestered that it is possible to have the foot pedal just under the frame to where if someone sits on the table it actuates the pedal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2872331
MDR Report Key2872331
Report Source99
Date Received2012-12-05
Date of Report2012-11-13
Date of Event2012-11-08
Date Facility Aware2012-11-08
Report Date2012-11-13
Date Reported to FDA2012-11-14
Date Reported to Mfgr2012-11-14
Date Added to Maude2012-12-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePHYSICAL THERAPY TREATMENT TABLE
Product CodeINQ
Date Received2012-12-05
Model NumberTRT-200
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP, INC.
Manufacturer Address4717 ADAMS RD. EIXTON TN 37343 US 37343


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2012-12-05

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