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..
[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
Report Number | 2872331 |
MDR Report Key | 2872331 |
Report Source | 99 |
Date Received | 2012-12-05 |
Date of Report | 2012-11-13 |
Date of Event | 2012-11-08 |
Date Facility Aware | 2012-11-08 |
Report Date | 2012-11-13 |
Date Reported to FDA | 2012-11-14 |
Date Reported to Mfgr | 2012-11-14 |
Date Added to Maude | 2012-12-14 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Generic Name | PHYSICAL THERAPY TREATMENT TABLE |
Product Code | INQ |
Date Received | 2012-12-05 |
Model Number | TRT-200 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CHATTANOOGA GROUP, INC. |
Manufacturer Address | 4717 ADAMS RD. EIXTON TN 37343 US 37343 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-12-05 |