Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-01239-1 |
Product Name/Description |
Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)
Part Numbers: G92756 and G94499
ARTG Number: 132260 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
28/11/2013 |
Responsible Entity |
|
Reason/Issue |
The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable AC3000 Spring Arm and fallen down together with the monitor until it was only held by the electrical cable connections. An inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. Investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. The frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Drager is advising users that the monitor arms will be inspected and repaired if required. Drager is also providing instructions to be followed by technically trained personnel, and will provide the required locking elements for replacement. |
Contact Information |
1800 800 327 - Draeger Medical Australia |